Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
2,000
Countries
9
Sites
74
Obesity or Overweight Without Type 2 Diabetes
To evaluate the effect of RO7795068 compared with placebo on weight management with respect to Percent (%) change from baseline in body weight at Week 72
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 8 May 2026 → ongoing
- Decision date (initial)
- 2026-05-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others, Efficacy
To evaluate the effect of RO7795068 compared with placebo on weight management with respect to Percent (%) change from baseline in body weight at Week 72
Secondary objectives 20
- To evaluate the effect of RO7795068 compared with placebo on weight management with respect to achieve ≥ 5%, ≥ 10%, ≥ 15%, ≥ 20% and ≥ 25% body weight loss at Week 72 (Yes/No) under treatment with RO7795068
- To evaluate the effect of RO7795068 compared with placebo on weight management with respect to achieve ≥ 5%, ≥ 10% and ≥ 15% body weight loss at Week 72 (Yes/No) under treatment with RO7795068
- To evaluate the effect of RO7795068 compared with placebo on weight management with respect to change from baseline in body weight (kg) at Week 72
- To evaluate the effect of RO7795068 compared with placebo on anthropometric measurements with respect to change from baseline in waist circumference (cm) at Week 72
- To evaluate the effect of RO7795068 compared with placebo on glycemic control
- To evaluate the effect of RO7795068 compared with placebo on cardiovascular and metabolic measures
- To evaluate the effect of RO7795068 compared with placebo on physical functioning
- To evaluate the effect of RO7795068 compared with placebo on anthropometric measurements
- To evaluate the effect of pooled doses of RO7795068 compared with placebo on glycemic control among patients with prediabetes at baseline
- To evaluate the effect of pooled doses of RO7795068 compared with placebo on hunger and satiety
- To evaluate the effect of pooled doses of RO7795068 compared with placebo on urinary incontinence among female patients with urinary incontinence at baseline
- To evaluate the effect of pooled doses of RO7795068 compared with placebo on physical functioning among patients with impaired physical functioning at baseline
- To evaluate the effect of pooled doses of RO7795068 compared to placebo on health-related quality of life (HRQoL)
- To evaluate the effect of pooled doses of RO7795068 compared with placebo on cardiovascular and metabolic measures
- To evaluate the effect of RO7795068 compared with placebo on weight management with respect to achieve ≥30% body weight loss at Week 72 (Yes/No)
- To evaluate the effect of RO7795068 compared with placebo on weight management with respect to change from baseline in BMI and percent change from baseline in weight by obesity class, at Week 72
- To evaluate the effect of RO7795068 compared to placebo on weight management with respect to time to achieve ≥ 5%, ≥10%, ≥15%, ≥20%, ≥25% and ≥30% weight loss from baseline through Week 72 (weeks)
- To evaluate the effect of RO7795068 compared to placebo on weight management with respect to time to achieve ≥ 5%, ≥10% and ≥15% weight loss from baseline through Week 72 (weeks)
- To evaluate the effect of pooled doses of RO7795068 compared with placebo in body composition by MRI (MRI substudy participants)
- To evaluate the safety and tolerability of RO7795068
Conditions and MedDRA coding
Obesity or Overweight Without Type 2 Diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
- IPD plan description
- N/A
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age ≥ 18 years at the time of signing Informed Consent Form
- Ability and willingness to comply with all aspects of the protocol including completion of all procedures, study visits, questionnaires, assessments for the duration of the study
- Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
- Body mass index (BMI) ≥ 30.0 kg/m2 OR BMI ≥ 27.0 and <30.0 kg/m2 and diagnosed with at least one of the following weight-related comorbidities: – Prediabetes as defined by the 2025 American Diabetes Association (ADA) Standards of Medical Care in Diabetes, i.e., HbA1c 5.7–6.4% (39–47 mmol/mol) or fasting plasma glucose 100–125 mg/dL (5.6–6.9 mmol/L) as determined by laboratory test during screening – Hypertension: defined as current stable use (minimum 4 weeks prior to screening) of blood pressure lowering agents initiated for hypertension, or with systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥ 80 mm Hg during screening – Dyslipidemia: defined as current stable use (minimum 4 weeks prior to screening) of lipid-lowering agents initiated for dyslipidemia, or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) < 40 mg/dL (1.0 mmol/L) for men or HDL < 50 mg/dL (1.3 mmol/L) for women as determined by laboratory test during screening – Obstructive sleep apnea – Weight-related cardiovascular disease (including, but not limited to, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure)
- History of ≥ 1 self-reported unsuccessful diet/exercise effort to lose body weight
- Agreement to adhere to the contraception requirements
Exclusion criteria 6
- History of Type 1 Diabetes Mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
- Self-reported change in body weight >5 kg within 3 months prior to screening
- Obesity induced by other endocrinologic disorders (e.g., Cushing’s syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
- Prior or planned surgical treatment for obesity Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
- Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
- History of acute or chronic pancreatitis or clinically significant gallbladder disease History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent (%) change from baseline in body weight at Week 72
Secondary endpoints 41
- Achieve ≥5% body weight loss at Week 72 (Yes/No)
- Achieve ≥10% body weight loss at Week 72 (Yes/No)
- Achieve ≥15% body weight loss at Week 72 (Yes/No)
- Achieve ≥20% body weight loss at Week 72 (Yes/No)
- Achieve ≥25% body weight loss at Week 72 (Yes/No)
- Change from baseline in body weight (kg) at Week 72
- Change from baseline in waist circumference (cm) at Week 72
- Change from baseline in fasting glucose at Week 72
- Change from baseline in fasting insulin at Week 72
- Change from baseline in LDL cholesterol at Week 72
- Change from baseline in HDL cholesterol at Week 72
- Change from baseline in triglyceride at Week 72
- Change from baseline in systolic blood pressure at Week 72
- Change from baseline in physical functioning as assessed by physical functioning domain of Short Form (36) Health Survey Version 2 Acute Form (SF-36v2 Acute Form) at Week 72
- Change from baseline in physical functioning composite as assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) at Week 72
- Change from baseline in waist-to-hip ratio at Week 72
- Change from baseline in waist-to-height ratio at Week 72
- Achieve normoglycemia (hemoglobin A1c (HbA1c) < 5.7%) at Week 72 (Yes/No)
- Change from baseline in Control of Eating Questionnaire (CoEQ) subscale scores for craving control, positive mood, craving for savory and craving for sweet; and the individual hunger item score at Week 72
- Change from baseline on symptoms and impact of urinary incontinence as assessed by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at Week 72
- Experience no change, improvement, or worsening in Patient Global Impression of Change (PGI-C) Urinary Incontinence at Week 72
- Experience no change, improvement, or worsening in Patient Global Impression of Severity/Status (PGI-S) Urinary Incontinence at Week 72
- Experience no change, improvement, or worsening in PGI-C Physical Functioning at Week 72
- Experience no change, improvement, or worsening in PGI-S Physical Functioning at Week 72
- Change from baseline in HRQoL as assessed by SF-36v2 Acute Form domain scores and component summary scores at Week 72
- Change from baseline in HRQoL as assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) domain scores and total score at Week 72
- Change from baseline at Week 72 in non-HDL cholesterol
- Change from baseline at Week 72 in VLDL cholesterol
- Change from baseline at Week 72 in total cholesterol
- Change from baseline at Week 72 in free fatty acids
- Change from baseline at Week 72 in diastolic blood pressure
- Change from baseline at Week 72 in high-sensitivity C-reactive protein (hsCRP)
- Achieve ≥30% body weight loss at Week 72 (Yes/No)
- Change from baseline in BMI at Week 72
- Percent change from baseline in weight by obesity class, at Week 72
- Time to achieve ≥5%, ≥10%, ≥15%, ≥20%, ≥25% and 30% weight loss from baseline through Week 72 (weeks)
- Change from baseline in total lean tissue volume (liter and %) at Week 72
- Change from baseline in total adipose tissue volume (liter and %) at Week 72
- Incidence and severity of adverse events (AEs) (including SAEs, AESIs and AEs leading to study drug discontinuation), with severity determined according to mild/moderate/severe criteria
- Change from baseline in selected safety laboratory values, vital signs, and ECGs through Week 72
- Changes from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire-9 (PHQ-9) through Week 72
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD13207526 · Product
- Active substance
- N-2-3-CYANO-5-FLUOROPHENYL-2-METHYL-1-OXOPROPYL-BETA-ALANYL-L-ALPHA-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L-ALPHA-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-ALPHA-ASPARTYL-L-LYSYL-L-ISOLEUCYL-L-ALANYL-L-GLUTAMINYL-N6-N-19-CARBOXY-1-OXONONADECYL-L-GAMMA-GLUTAMYL-2-2-2-AMINOETHOXYETHOXYACETYL-2-2-2-AMINOETHOXYETHOXYACETYL-L-LYSYL-L-ALANYL-L-PHENYLALANYL-L-VALYL-L-GLUTAMINYL-L-TRYPTOPHYL-L-LEUCYL-L-ISOLEUCYL-L-ALANYLGLYCYLGLYCYL-L-PROLYL-L-SERYL-L-SERYLGLYCYL-L-ALANYL-L-PROLYL-L-PROLYL-L-PROLYL-L-SERINAMIDE
- Other product name
- CT-388
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ROUTE OF ADMINISTRATION NOT APPLICABLE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD13207529 · Product
- Active substance
- N-2-3-CYANO-5-FLUOROPHENYL-2-METHYL-1-OXOPROPYL-BETA-ALANYL-L-ALPHA-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L-ALPHA-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-ALPHA-ASPARTYL-L-LYSYL-L-ISOLEUCYL-L-ALANYL-L-GLUTAMINYL-N6-N-19-CARBOXY-1-OXONONADECYL-L-GAMMA-GLUTAMYL-2-2-2-AMINOETHOXYETHOXYACETYL-2-2-2-AMINOETHOXYETHOXYACETYL-L-LYSYL-L-ALANYL-L-PHENYLALANYL-L-VALYL-L-GLUTAMINYL-L-TRYPTOPHYL-L-LEUCYL-L-ISOLEUCYL-L-ALANYLGLYCYLGLYCYL-L-PROLYL-L-SERYL-L-SERYLGLYCYL-L-ALANYL-L-PROLYL-L-PROLYL-L-PROLYL-L-SERINAMIDE
- Other product name
- CT-388
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ROUTE OF ADMINISTRATION NOT APPLICABLE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD13207531 · Product
- Active substance
- N-2-3-CYANO-5-FLUOROPHENYL-2-METHYL-1-OXOPROPYL-BETA-ALANYL-L-ALPHA-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L-ALPHA-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-ALPHA-ASPARTYL-L-LYSYL-L-ISOLEUCYL-L-ALANYL-L-GLUTAMINYL-N6-N-19-CARBOXY-1-OXONONADECYL-L-GAMMA-GLUTAMYL-2-2-2-AMINOETHOXYETHOXYACETYL-2-2-2-AMINOETHOXYETHOXYACETYL-L-LYSYL-L-ALANYL-L-PHENYLALANYL-L-VALYL-L-GLUTAMINYL-L-TRYPTOPHYL-L-LEUCYL-L-ISOLEUCYL-L-ALANYLGLYCYLGLYCYL-L-PROLYL-L-SERYL-L-SERYLGLYCYL-L-ALANYL-L-PROLYL-L-PROLYL-L-PROLYL-L-SERINAMIDE
- Other product name
- CT-388
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ROUTE OF ADMINISTRATION NOT APPLICABLE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD13207527 · Product
- Active substance
- N-2-3-CYANO-5-FLUOROPHENYL-2-METHYL-1-OXOPROPYL-BETA-ALANYL-L-ALPHA-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L-ALPHA-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-ALPHA-ASPARTYL-L-LYSYL-L-ISOLEUCYL-L-ALANYL-L-GLUTAMINYL-N6-N-19-CARBOXY-1-OXONONADECYL-L-GAMMA-GLUTAMYL-2-2-2-AMINOETHOXYETHOXYACETYL-2-2-2-AMINOETHOXYETHOXYACETYL-L-LYSYL-L-ALANYL-L-PHENYLALANYL-L-VALYL-L-GLUTAMINYL-L-TRYPTOPHYL-L-LEUCYL-L-ISOLEUCYL-L-ALANYLGLYCYLGLYCYL-L-PROLYL-L-SERYL-L-SERYLGLYCYL-L-ALANYL-L-PROLYL-L-PROLYL-L-PROLYL-L-SERINAMIDE
- Other product name
- CT-388
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ROUTE OF ADMINISTRATION NOT APPLICABLE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD13207528 · Product
- Active substance
- N-2-3-CYANO-5-FLUOROPHENYL-2-METHYL-1-OXOPROPYL-BETA-ALANYL-L-ALPHA-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L-ALPHA-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-ALPHA-ASPARTYL-L-LYSYL-L-ISOLEUCYL-L-ALANYL-L-GLUTAMINYL-N6-N-19-CARBOXY-1-OXONONADECYL-L-GAMMA-GLUTAMYL-2-2-2-AMINOETHOXYETHOXYACETYL-2-2-2-AMINOETHOXYETHOXYACETYL-L-LYSYL-L-ALANYL-L-PHENYLALANYL-L-VALYL-L-GLUTAMINYL-L-TRYPTOPHYL-L-LEUCYL-L-ISOLEUCYL-L-ALANYLGLYCYLGLYCYL-L-PROLYL-L-SERYL-L-SERYLGLYCYL-L-ALANYL-L-PROLYL-L-PROLYL-L-PROLYL-L-SERINAMIDE
- Other product name
- CT-388
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ROUTE OF ADMINISTRATION NOT APPLICABLE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD13207530 · Product
- Active substance
- N-2-3-CYANO-5-FLUOROPHENYL-2-METHYL-1-OXOPROPYL-BETA-ALANYL-L-ALPHA-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L-ALPHA-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-ALPHA-ASPARTYL-L-LYSYL-L-ISOLEUCYL-L-ALANYL-L-GLUTAMINYL-N6-N-19-CARBOXY-1-OXONONADECYL-L-GAMMA-GLUTAMYL-2-2-2-AMINOETHOXYETHOXYACETYL-2-2-2-AMINOETHOXYETHOXYACETYL-L-LYSYL-L-ALANYL-L-PHENYLALANYL-L-VALYL-L-GLUTAMINYL-L-TRYPTOPHYL-L-LEUCYL-L-ISOLEUCYL-L-ALANYLGLYCYLGLYCYL-L-PROLYL-L-SERYL-L-SERYLGLYCYL-L-ALANYL-L-PROLYL-L-PROLYL-L-PROLYL-L-SERINAMIDE
- Other product name
- CT-388
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ROUTE OF ADMINISTRATION NOT APPLICABLE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Axon Communications Inc. ORL-000017462
|
Toronto, Canada | Other |
| Pharmaceutical Research Associates Group B.V. ORG-100006268
|
Assen, Netherlands | Other |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Q2q Communications Limited ORG-100041455
|
Richmond, United Kingdom | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Pra International ORG-100032850
|
Lenexa, United States | Other |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Other |
Locations
9 EU/EEA countries · 74 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 58 | 5 |
| Czechia | Ongoing, recruiting | 91 | 7 |
| France | Authorised, recruitment pending | 84 | 9 |
| Germany | Ongoing, recruiting | 100 | 12 |
| Hungary | Ongoing, recruiting | 79 | 7 |
| Italy | Ongoing, recruiting | 88 | 9 |
| Netherlands | Authorised, recruitment pending | 51 | 5 |
| Poland | Ongoing, recruiting | 98 | 10 |
| Spain | Ongoing, recruiting | 105 | 10 |
| Rest of world
Brazil, Taiwan, United States, India, United Kingdom, Mexico, Canada, Korea, Republic of, China, Australia, Japan, Argentina
|
— | 1,246 | — |
Investigational sites
Centre hospitalier universitaire de Liege
Diabetes, nutrition and metabolic disorder, Avenue De L'Hopital 1, 4000, Liege
Hopital Erasme
Endocrinology, Lennikse Baan 808, 1070, Anderlecht
Onze-Lieve-Vrouwziekenhuis
Endocrinology, Moorselbaan 164, 9300, Aalst
Algemeen Ziekenhuis Delta
Endocrinology, Deltalaan 1, 8800, Roeselare
UZ Leuven
Endocrinology, Herestraat 49, 3000, Leuven
Vseobecna Fakultni Nemocnice V Praze
III. interní klinika, U Nemocnice 504/1 Nove Mesto, 128 00, Prague
MUDr. Alena Váchová
Diabetologie, České Vrbné 2403, 37011, České Budějovice
Medispo s.r.o.
obezitologie, Sokolská 31, 12000, Praha 2
DiaVize s.r.o.
diabetologie, Budejovicka 778/3a, Michle, Prague
Dialine s.r.o.
obezitologie, Tylova 502/39, Jizni Predmesti, Plzen 3
MEDICON a.s.
Diabetologie, Antala Staska 1670/80, Krc, Prague 4
Edumed s.r.o.
Diabetologická ambulance, Mlynska 189, 547 01, Nachod
Centre Hospitalier Universitaire De Nantes
Service d'Endocrinologie-Diabétologie-Nutrition, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Bordeaux
Service d’endocrinologie, diabétologie et nutrition, 66 Avenue De Magellan, 33608, Pessac Cedex
Centre Hospitalier Universitaire De Poitiers
Service d’endocrinologie, diabétologie et nutrition, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire Rouen
Service Endocrinologie, Diabète et Maladies Métaboliques - Centre de Nutrition, 147 Avenue Du Marechal Juin, 76230, Bois-Guillaume
Centre Hospitalier Regional D'Angers
Service d’endocrinologie, diabétologie et nutrition, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Dijon
Service d’endocrinologie, diabétologie maladie métabolique et nutrition, 14 Rue Paul Gaffarel, 21000, Dijon
Assistance Publique Hopitaux De Paris
service de nutrition, 20 Rue Leblanc, 75015, Paris
Assistance Publique Hopitaux De Paris
service d'endocrinologie et métabolisme, 43 Boulevard De L Hopital, 75013, Paris
Hospices Civils De Lyon
Endocrinologie Diabète et Nutrition, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Zentrum für klinische Forschung
Zentrum für klinische Forschung, Berliner Str. 895, 51069, Köln
Medicover Medizin gGmbH
Medicover Neuroendokrinologie MVZ, Orleansplatz 3, Au-Haidhausen, Munich
Uhz Klinische Forschung
Unterfrintoper Hausarztzentrum, Unterstrasse 75, Frintrop, Essen
Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage
Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Düesbergweg 128, Nordrhein-Westfalen, Münster
Universitaetsklinikum Frankfurt AöR
Med. Klinik 1, Theodor-Stern-Kai 7, Sachsenhausen, Frankfurt Am Main
Diabetologische Schwerpunktpraxis Pirna
Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung, Königsteiner Strasse 6b, 01796, Pirna
Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle
Gemeinschaftspraxis Dr. Wendisch Ulrich, Dr. Dahl Dominik und Prof. Dr. Aberle Jens, Beserlerstraße 2 A, 22607, Hamburg
Universitaetsklinikum Erlangen AöR
Medizinische Klinik I- Gastroenterologie, Pneumologie und Endokrinologie, Ulmenweg 18, Innenstadt, Erlangen
Mesut Durmaz Schwerpunktpraxis für Diabetes, Hormone & Stoffwechsel Studienzentrum
Schwerpunktpraxis für Diabetes, Hormone & Stoffwechsel, Studienzentrum, August-Mohl-Straße 37, 95030, Hof
Medizentrum Essen Borbeck
Medizentrum Essen-Borbeck, Huelsmannstrasse 6, Borbeck, Essen
InnoDiab Forschung GmbH
InnoDiab, Eleonorastrasse 42, Ruettenscheid, Essen
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Klinik für Diabetologie und Endokrinologie, Georgstrasse 11, Innenstadt, Bad Oeynhausen
Szatmari-Med Kft.
Diabetologia, Iv Utca 30/B, 1215, Budapest XXI
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Diabetologia, Seregelyesi Ut 3, 8000, Szekesfehervar
University Of Szeged
Klinikai Farmakológiai Központ, Koranyi Fasor 6, 6720, Szeged
Semmelweis University
Sziv- es Ergyogyaszati Klinika, Varosmajor Utca 68, Kerulet, Budapest XII
DRC Kft.
Ambulancia, Ady Endre Utca 12/b, 8230, Balatonfured
University Of Debrecen
Belgyogyaszati Klinika, Nagyerdei Korut 98, 4032, Debrecen
Med-Tima Kft.
Diabetologia, Gyongyhaz Utca 2/I./em. 4, XIII Kerulet, Budapest XIII
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
SC Malattie Endocrine-Diabetologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero Universitaria Pisana
Endocrinology unit 1, Via Paradisa 2, 56124, Pisa
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
UO Complessa di Endocrinologia, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O.C. Endocrinologia e prevezione e cura del diabete, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Di Perugia
S.C. di Endocrinologia e Malattie Metaboliche, Piazzale Giorgio Menghini 9, 06129, Perugia
Policlinico San Donato S.p.A.
Endocrinology unit, Piazza Edmondo Malan 2, 20097, San Donato Milanese
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Patologie dell'Obesità, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero Universitaria Renato Dulbecco
U.O.C. di Malattie del Metabolismo, Viale Europa, 88100, Catanzaro
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Clinical Nutrition, Obesity and Metabolism, Via Del Vespro 129, 90127, Palermo
Radboud universitair medisch centrum Stichting
Interne Geneeskunde, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Isala Klinieken Stichting
Vasculair geneeskundige, Dokter Van Heesweg 2, 8025 AB, Zwolle
Universitair Medisch Centrum Utrecht
Vasculaire Geneeskunde & Endocrinologie, Heidelberglaan 100, 3584 CX, Utrecht
Amsterdam UMC Stichting
Vasculaire Geneeskunde, Meibergdreef 9, 1105 AZ, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Interne Geneeskunde, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna
NA, ul. Północna 24/U3, 20-064, Lublin
Centrum Medyczne All-Med Badania Kliniczne
NA, Ul. Henryka Sienkiewicza 23, 30-033, Cracow
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
NZOZ Centrum Medyczne KERmed Poradnia Kardiologiczna, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny
Poradnia Diabetologiczna, Ul. Ludwika Zamenhofa 10/20, 15-435, Bialystok
Metabolica Sp. z o.o.
NZOZ METABOLICA - Ośrodek Badań Klinicznych, Ul. Najswietszej Marii Panny 9b, 33-100, Tarnow
Clinicly Sp. z o.o.
Centrum Medyczne Clinicly, Ul. Ludwika Warynskiego 30, 45-047, Opole
Indywidualna Specjalistyczna Praktyka Lekarska w dziedzinie kardiologii Lek med. Krzysztof Cymerman
NA, ul. mjr. Henryka Sucharskiego 2, 81-157, Gdynia
Etg Zamosc Sp. z o.o.
ETG Zamość Poradnie Specjalistyczne, Ul. Gesia 3, 22-400, Zamosc
Etg Warszawa Sp. z o.o.
Poradnie ETG Warszawa, Ul. Wynalazek 4, 02-677, Warsaw
American Heart Of Poland S.A.
Kliniki Serca X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji, Ul. Edukacji 102, 43-100, Tychy
Hospital Clinico San Carlos
Endrocrinology, Calle De Martin Fierro Sn, 28040, Madrid
Clinica Universidad De Navarra
Endrocrinology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Nisa Sevilla Aljarafe
Endrocrinology, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Ruber Juan Bravo
Endrocrinology, Calle De Juan Bravo 49, 28006, Madrid
Hospital Del Mar
Endrocrinology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Y Politecnico La Fe
Endrocrinology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Vall D Hebron
Endrocrinology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Instituto Medico Quirurgico San Rafael S.A.
Endrocrinology, Poboado Nucleo Rural La Jubias 82, 15006, A Coruna
Hospital Universitario Marques De Valdecilla
Endrocrinology, Avenida Valdecilla Sn, 39008, Santander
Hospital Quironsalud Infanta Luisa
Endrocrinology, Calle De San Jacinto 87, 41010, Sevilla
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2026-05-26 | 2026-05-27 | |||
| Germany | 2026-05-08 | 2026-05-11 | |||
| Hungary | 2026-05-21 | 2026-05-26 | |||
| Italy | 2026-05-28 | 2026-06-03 | |||
| Poland | 2026-05-19 | 2026-05-26 | |||
| Spain | 2026-05-18 | 2026-05-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 113 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2025-523104-71-00-redacted | 1 |
| Protocol (for publication) | d4_patient-facing-documents_memo | N/A |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF Procedure | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | NA |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Study WC45725 | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements_WC45725_CZ | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Material__Patient Letter | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Material__Study Brochure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Material__Study Flyer | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Material__Study Postcards | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Material__Study Postcards_CVRM | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_CVRM Study Postcard | 1 |
| Recruitment arrangements (for publication) | K2_D and I Leaflet | 2 |
| Recruitment arrangements (for publication) | K2_Document additionnel_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Assets Online Adds_WC45725 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CVRM Postcard_WC45725 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_WC45725 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Letter | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Letter_WC45725 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pre Screening Questionaire_WC45725 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study brochure_EN | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study brochure_FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study brochure_NL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Brochure_WC45725 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study flyer_EN | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study flyer_FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study flyer_NL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Flyer_WC45725 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Postcard | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study postcard_EN | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study postcard_FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study postcard_NL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Postcard_WC45725 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Poster_WC45725 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Website_WC45725 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Patient letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Study Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Study flyer | 1 |
| Recruitment arrangements (for publication) | K3_recruitment material_patient letter | 1 |
| Recruitment arrangements (for publication) | K3_recruitment material_Study Brochure | 1 |
| Recruitment arrangements (for publication) | K3_recruitment material_Study flyer | 1 |
| Recruitment arrangements (for publication) | K3_recruitment material_study Postcard | 1 |
| Subject information and informed consent form (for publication) | L1_ICF RBR | 1 |
| Subject information and informed consent form (for publication) | L1_Patient Card_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form other subjects | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF biosamples | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_WC45725 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_NL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_redacted | V1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_WC45725_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MRI | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MRI HV | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MRI Volunteers | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF newborn | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional MRI | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional MRI Patients | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_WC45725 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR_WC45725 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR_WC45725_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_WC45725_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infants | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IRM substudy | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_WC45725_CZ_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MRI_WC45725_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional MRI | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_optional MRI_WC45725_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_WC45725_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Volunteer MRI_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS RBR | 1 |
| Subject information and informed consent form (for publication) | L1_WC45725 Summary of pt material | 2 |
| Subject information and informed consent form (for publication) | L2_other SI material_Patient Participation Card_WC45725_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_instruction utilisation | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_IFU | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Thank you letter | 1 |
| Subject information and informed consent form (for publication) | L2_Sponsor Statement On Use of ICF Model | 1.0 |
| Subject information and informed consent form (for publication) | L3_other SI material_redaction memo | 1 |
| Subject information and informed consent form (for publication) | WC45725_IAF_v1_2026_01_09_ES | 1 |
| Subject information and informed consent form (for publication) | WC45725_ICF General_v1_2026_01_09_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | WC45725_ICF RBR_v1_2026_01_09_ES | 1 |
| Subject information and informed consent form (for publication) | WC45725_ICF RM_ participantes_v1_2026_01_14_ES | 1 |
| Subject information and informed consent form (for publication) | WC45725_ICF RM_voluntario_v1_2026_01_09_ES | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-de-2025-523104-71-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-fr-2025-523104-71-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_be-nl-2025-523104-71-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_cz-2025-523104-71-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2025-523104-71-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2025-523104-71-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-fr-2025-523104-71-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_hu-2025-523104-71-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2025-523104-71-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_nl-nl-2025-523104-71-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2025-523104-71-00 | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-19 | Spain | Acceptable 2026-05-06
|
2026-05-07 |