Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
1,602
Countries
8
Sites
67
Obesity or Overweight and 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
- 25 May 2026 → ongoing
- Decision date (initial)
- 2026-05-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche Ltd
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 21
- 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 achieve ≥ 5% and ≥ 10% 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 glycemic control with respect to change from baseline in hemoglobin A1c (HbA1c) at Week 72
- To evaluate the effect of RO7795068 compared with placebo on glycemic control with respect to achieve HbA1c of ≤ 6.5% and <7% Week 72 (Yes/No)
- 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 with respect to change from baseline in fasting glucose at Week 72
- 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 RO7795068 compared with placebo on hunger and satiety
- To evaluate the effect of RO7795068 compared with placebo on urinary incontinence among female patients with urinary incontinence at baseline
- To evaluate the effect of RO7795068 compared with placebo on physical functioning among patients with impaired physical functioning at baseline
- To evaluate the effect of RO7795068 compared to placebo on health-related quality of life (HRQoL)
- To evaluate the effect of RO7795068 compared with placebo on cardiovascular and metabolic measures
- To evaluate the effect of RO7795068 compared with placebo on albuminuria
- To evaluate the effect of RO7795068 compared with placebo on weight management
- 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% and ≥15% weight loss from baseline through Week 72 (weeks)
- To evaluate the effect of RO7795068 compared with placebo on glycemic control with respect to achieve HbA1c of < 5.7% at Week 72 (Yes/No)
- To evaluate the safety and tolerability of RO7795068
Conditions and MedDRA coding
Obesity or Overweight and 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)
- BMI ≥27.0 kg/m²
- Diagnosis of T2DM according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral AHM (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
- History of ≥ 1 self-reported unsuccessful diet/exercise effort to lose body weight
Exclusion criteria 6
- History of Type 1 Diabetes Mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
- At least 2 confirmed fasting BG values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
- 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)
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)
- Change from baseline in body weight (kg) at Week 72
- Change from baseline in HbA1c at Week 72
- Achieve HbA1c of ≤ 6.5% at Week 72 (Yes/No)
- Achieve HbA1c of <7% at Week 72 (Yes/No)
- 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
- 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)
- Change from baseline in urinary albumin/creatinine ratio at Week 72
- Achieve ≥ 15% 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% and ≥15% weight loss from baseline through Week 72 (weeks)
- Achieve HbA1c of < 5.7% at Week 72 (Yes/No)
- 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
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
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 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
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
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
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
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
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 6
| Organisation | City, country | Duties |
|---|---|---|
| Axon Communications Inc. ORL-000017462
|
Toronto, Canada | Other |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
| Pra International ORG-100032850
|
Lenexa, United States | Other |
| Pharmaceutical Research Associates Group B.V. ORG-100006268
|
Assen, Netherlands | Other |
Locations
8 EU/EEA countries · 67 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 63 | 7 |
| France | Authorised, recruitment pending | 40 | 5 |
| Germany | Ongoing, recruiting | 80 | 12 |
| Hungary | Not authorised | 64 | 7 |
| Italy | Authorised, recruitment pending | 73 | 9 |
| Poland | Authorised, recruiting | 78 | 10 |
| Romania | Authorised, recruitment pending | 73 | 7 |
| Spain | Authorised, recruiting | 80 | 10 |
| Rest of world
Thailand, India, Japan, Australia, Argentina, Brazil, Canada, Korea, Republic of, United States, Mexico, United Kingdom, Taiwan, Turkey, China
|
— | 1,051 | — |
Investigational sites
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
Diabetologické centrum, U Vojenske Nemocnice 1200, 169 02, Prague 6
DIACENTRUM Brandys n.L. s.r.o.
Diacentrum, Jiriho Wolkera 603/1, 250 01, Brandys Nad Labem
Vseobecna Fakultni Nemocnice V Praze
III. interní klinika, U Nemocnice 504/1 Nove Mesto, 128 00, Prague
Institute for Clinical and Experimental Medicine
Centrum Diabetologie, Vídeňská 1958, 140 21 Praha 4, Prague
TreDia s.r.o.
endokrinologie a diabetologie, Axmanova 131/1, 190 14, Praha
Interni, Diabetologicka a Obezitologicka Ambulance
Interni, Diabetologicka a Obezitologicka Ambulance, Říčanská 1177, 25242, Jesenice
FLEDIP s.r.o.
diabetologická ambulance, Na Dlouhém lánu 11, 16000, Praha 6
Centre Hospitalier Regional De Marseille
Service d'Endocrinologie, Maladies métaboliques, et Nutrition, 147 Boulevard Baille, 13005, Marseille
Centre Hospitalier Regional Universitaire De Tours
Nutrition, Pédiatrie, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Assistance Publique Hopitaux De Paris
Service de Nutrition, 20 Rue Leblanc, 75908, Paris Cedex 15
Centre Hospitalier Universitaire De Nice
Endocrinologie - Diabétologie, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Saint Joseph Saint Luc
Endocrinologie - Diabétologie, 20 Quai Claude Bernard, 69007, Lyon
Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage
Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Düesbergweg 128, Nordrhein-Westfalen, Münster
Zentrum für klinische Forschung
Zentrum für klinische Forschung, Berliner Str. 895, 51069, Köln
Universitaetsklinikum Erlangen AöR
Medizinische Klinik I- Gastroenterologie, Pneumologie und Endokrinologie, Ulmenweg 18, Innenstadt, Erlangen
MVZ Diabeteszentrum Dr. Tews GmbH
Praxis für Diabetologie, Herzbachweg 14e, 63571, Gelnhausen
Mesut Durmaz Schwerpunktpraxis für Diabetes, Hormone & Stoffwechsel Studienzentrum
Praxis, August-Mohl-Straße 37, 95030, Hof
InnoDiab Forschung GmbH
InnoDiab, Eleonorastrasse 42, Ruettenscheid, Essen
Medizentrum Essen Borbeck
Medizentrum Essen-Borbeck, Huelsmannstrasse 6, Borbeck, Essen
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Klinik für Diabetologie und Endokrinologie, Georgstrasse 11, Innenstadt, Bad Oeynhausen
Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle
Studienzentrum, Beserlerstraße 2 A, 22607, Hamburg
Uhz Klinische Forschung
Unterfrintoper Hausarztzentrum, Unterstrasse 75, Frintrop, Essen
Universitaetsklinikum Frankfurt AöR
Medizinische Klinik 1, Theodor-Stern-Kai 7, Sachsenhausen, Frankfurt Am Main
Diabetologische Schwerpunktpraxis Pirna
Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung, Königsteiner Strasse 6b, 01796, Pirna
Semmelweis University
Belgyogyaszati és Onkolgiai Klinika, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Med-Tima Kft.
Belvarosi Anyagcsere Centrum, Gyongyhaz Utca 2/I./em. 4, XIII Kerulet, Budapest XIII
ClinDiab Kft.
Benyovszky Orvosi Kozpont, Benyovszky Moric Utca 10/VIII, VIII Kerulet, Budapest VIII
University Of Szeged
Szent-Gyorgyi Albert Klinikai Kozpont, Belgyogyaszati Klinika, Kalvaria Sugarut 57, 6725, Szeged
DRC Kft.
Gyogyszervizsgaló Kozpont, Ady Endre Utca 12/b, 8230, Balatonfured
University Of Debrecen
Klinikai Kozpont, Belgyogyaszati Klinika, A epulet, Nagyerdei Korut 98, 4032, Debrecen
Semmelweis University
Varosmajori Sziv- es Ergyogyaszati Klinika, Varosmajor Utca 68, Kerulet, Budapest XII
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Diabetes Unit, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Endocrinology and Prevention and Treatment of Diabetes, Via Pietro Albertoni 15, 40138, Bologna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOSD Diabetology - Department of Abdominal, Endocrine and Metabolic Medical and Suirgical Sciences, Largo Francesco Vito 1, 00168, Rome
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
SC Malattie Endocrine - Diabetologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera Di Perugia
SC di Endocrinologia e Malattie Metaboliche, Piazzale Giorgio Menghini 9, 06129, Perugia
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Unit of Clinical Nutrition, Obesity and Metabolism, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliero Universitaria Renato Dulbecco
UOC Malattie del Metabolismo, Viale Europa, 88100, Catanzaro
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
UOC Endocrinology, Piazzale Giulio Cesare 11, 70124, Bari
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento Medico Polispecialistico – Diabetologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Lukmed 2 Sp. z o.o.
ETG SIEDLCE, Ul. Mlynarska 16 B, 08-110, Siedlce
"Osteo-Medic" spółka cywilna Artur Racewicz, Jerzy Supronik
Poradnia Diabetologiczna, Wiejska 81, 15-351, Białystok
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
Poradnia diabetologiczna, Ul. Piotra Niedurnego 50 D, 41-709, Ruda Slaska
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Centrum Diabetologiczne, Ul. Woloska 137, 02-507, Warsaw
Eskulap Pabianice Sp. z o.o.
Przychodnia Lekarska Eskulap Poradnia diabetologiczna Pabianice, Ul. Grobelna 8, 95-200, Pabianice
Ekamed Sp. z o.o.
Centrum Medyczne Ekamed Poradnia Diabetologiczna, Aleja Krasnicka 2j/u1, 20-718, Lublin
ETG Lublin Sp. z o.o.
ETG Dębica Poradnie Specjalistyczne, Ul. Czarnieckiego 5, 39-200, Debica
Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga Stasinska sp.p. Lekarzy
Poradnia diabetologiczna, Ul. Sw. Mikolaja 53/1a, 50-127, Wroclaw
Centrum Medyczne Intercor Sp. z o.o.
Poradnia Endokrynologiczno-Diabetologiczna, Ul. Kasztanowa 57, 85-605, Bydgoszcz
Centrum Medyczne Omedica Jaroslaw Opiela I Beata Opiela Sp. j.
Poradnia diabetologiczna, Ul. Steszewska 41/4, 60-111, Poznan
Top Diabet S.R.L.
Diabet zaharat, nutritie si boli metabolice, Block D2 Staircase 3 Apartment 2, Strada Calea Bucuresti No 58, Craiova
Diabmed Dr. Popescu Alexandrina S.R.L.
Diabet zaharat, nutritie si boli metabolice, Strada Sighet Nr 4, 100163, Ploiesti
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Diabet zaharat, nutritie si boli metabolice, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Consultmed S.R.L.
Diabet zaharat, nutritie si boli metabolice, Block 550, Soseaua Pacurari 70, Jassi
Nicodiab S.R.L.
Diabet zaharat, nutritie si boli metabolice, Strada Polona Nr 92, 010507, Bucharest
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Diabet zaharat, nutritie si boli metabolice, Bulevardul Liviu Rebreanu 156, 300723, Timisoara
Spitalul Clinic Judetean De Urgenta Cluj
Diabet zaharat, nutritie si boli metabolice, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Endrocrinology, Calle Alejo Fernandez 9, 41003, Sevilla
Complexo Hospitalario Universitario A Coruna
Endrocrinology, Lugar Jubias De Arriba 84, 15006, A Coruna
Centro Medico Teknon-Grupo Quironsalud
Endrocrinology, Calle Vilana 12, 08022, Barcelona
Hospital Universitario Quironsalud Madrid
Endrocrinology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Area Sanitaria De Ferrol
Endrocrinology, Avenida Residencia S/n, 15405, Ferrol
Hospital Universitari Vall D Hebron
Endrocrinology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Germans Trias I Pujol
Endocrinology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital General Universitario Gregorio Maranon
Endocrinology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Virgen De La Victoria
Endocrinology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitario Fundacion Jimenez Diaz
Endocrinology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
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 |
|---|---|---|---|---|---|
| Germany | 2026-05-27 | 2026-05-27 | |||
| Poland | 2026-05-28 | ||||
| Spain | 2026-05-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 91 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2025-523106-32-00-redacted | 1 |
| Protocol (for publication) | d4_patient-facing-documents_memo | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Study WC45726 | 2 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements_WC45726_CZ | 1 |
| 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 Postcard | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Material__Study Postcard_CVRM | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Study Brochure | 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_Assests Online Adds_WC45726 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CVRM Postcard_WC45726 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CVRM Study Postcard | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Letter_WC45726 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pre Screening Questionaire_WC45726 | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Study Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Brochure_WC45726 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Flyer_WC45726 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Postcard | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Postcard_WC45726 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Poster_WC45726 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Website_WC45726 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitrment material_Patient Flyer_WC45726 | 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_Privacy consent form other subjects | 1 |
| 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 Healthy Volunteer MR_REDACTED | 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_WC45726_RFI_clean | 2 |
| 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 Main REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_WC45726_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MRI Volunteers | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional MR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional MRI Patients | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_WC45726 | 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_WC45726 | 2 |
| 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_GDPR_WC45726_CZ | 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_locally adapted_EN_Clean | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_locally adapted_RO_Clean | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_WC45726_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IRM | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Locally Adapted_EN_Clean- Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Locally Adapted_RO_Clean -Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_WC45726_CZ_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MRI | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MRI_HV | 1 |
| 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_RBR_WC45726_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS RBR | 1 |
| Subject information and informed consent form (for publication) | L2_other SI material_Patient Participation Card_WC45726_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject info_Patient Card REDACTED | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Instructions for use | 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) | L3_other SI material_Redaction memo | NA |
| Subject information and informed consent form (for publication) | WC45726 Summary of patient materials_10Jan2026 | 1 |
| Subject information and informed consent form (for publication) | WC45726_IAF_ES | 1 |
| Subject information and informed consent form (for publication) | WC45726_ICF General_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | WC45726_ICF RBR_ES | 1 |
| Subject information and informed consent form (for publication) | WC45726_ICF RM_ participantes_ES | 1 |
| Subject information and informed consent form (for publication) | WC45726_ICF RM_voluntario_ES | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_cz-2025-523106-32-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2025-523106-32-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2025-523106-32-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-fr-2025-523106-32-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_hu-2025-523106-32-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2025-523106-32-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2025-523106-32-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_ro-2025-523106-32-00 | 1 |
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 with conditions 2026-05-11
|
2026-05-13 |