Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
234
Countries
2
Sites
15
Obesity
To assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment
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
- 7 Jul 2025 → ongoing
- Decision date (initial)
- 2025-06-23
- 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, Pharmacokinetic, Efficacy
To assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment
Secondary objectives 7
- To assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body measurements
- To assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body composition
- To assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on thigh muscles
- To assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on metabolic markers
- To assess the safety and tolerability of subcutaneous (SC) administered RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide
- To characterize the pharmacokinetics (PK) of RO7204239
- To evaluate immune response to RO7204239
Conditions and MedDRA coding
Obesity
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
| 24.1 | PT | 10033307 | Overweight | 100000004861 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Doble blind core tratement 4 arms combining Tirzepatide, GYM329 and placebo
|
Randomised Controlled | Double | [{"id":173858,"code":1,"name":"Subject"},{"id":173859,"code":2,"name":"Investigator"}] | Tirzepatide + placebo: Tirzepatide + placebo Tirzepatide + GYM329 dose X: Tirzepatide + GYM329 dose X Tirzepatide + GYM329 dose Y: Tirzepatide + GYM329 dose Y Tirzepatide + GYM329 dose Z: Tirzepatide + GYM329 dose Z |
| 2 | Extension treatment 24 W
|
Randomised Controlled | Double | [{"id":173862,"code":1,"name":"Subject"},{"id":173861,"code":2,"name":"Investigator"}] | Placebo: Placebo GYM329 dose Z: GYM329 dose Z |
| 3 | Follow up Period Follow up Period 24 W
|
Not Applicable | None |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- N/A
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-506761-65-00 | A Two-Part, Seamless, Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Patients With Spinal Muscular Atrophy | F. Hoffmann-La Roche AG |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Able and willing to provide written informed consent, to participate in all scheduled assessments, and to comply with the study protocol according to ICH and local regulations
- Male or female participants, aged 18 and above at the time of signing the ICF.
- BMI ≥ 27.0 kg/m² and <30.0 kg/m² with at least one weight-related comorbidity such as hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, cardiovascular disease
- History of at least one self-reported unsuccessful dietary or exercise effort to lose body weight
- Weight stability: self-reported change in body weight less than 5 kg (11 lbs) within 3 months prior to screening
- Agreement to adhere to the contraception requirements
Exclusion criteria 6
- Pregnant or breastfeeding, or with intention of becoming pregnant during the study or within the timeframe in which contraception is required
- Prior history or diagnosis of diabetes mellitus (T1DM, T2DM, or rare forms of diabetes mellitus) or historical or screening laboratory values suggestive of diabetes mellitus, defined as 1 or more values of HbA1c ≥ 6.5% (48 mmol/mol), fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L), or random glucose ≥ 200 mg/dL (11.1 mmol/L)
- Have 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 [MC4R] or Prader–Willi Syndrome).
- Participation in unbalanced/extreme diets (e.g., very low calorie, low carbohydrate, very high protein, ketogenic diets) or in an organized weight reduction program within 3 months of the screening visit or plans to engage in such diets or programs during the study.
- Have any of the following cardiovascular conditions within 6 months prior to screening: a) Acute myocardial infarction, b) Cerebrovascular accident (stroke), c) Unstable angina, or d) Hospitalization due to congestive heart failure.
- Have a history of NYHA Functional Classification III or IV congestive heart failure
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent (%) change in body weight from baseline at Week 48
Secondary endpoints 21
- Change from baseline at Week 48 Absolute change in body weight (kg)
- Change from baseline at Week 48 Change in body mass index (BMI) (kg/m2)
- Change from baseline at Week 48 Waist-to-height ratio
- Change from baseline at Week 48 Waist circumference
- Change from baseline at Week 48 in Total body fat mass (kg and %) by dual-energy x-ray absorptiometry (DXA)
- Change from baseline at Week 48 in Total lean body mass (kg and %) by DXA
- Change from baseline at Week 48 in Appendicular lean mass (kg and %) by DXA
- Change from baseline at Week 48 in Muscle volume (%) by magnetic resonance imaging (MRI)
- Change from baseline at Week 48 in Muscle fat infiltration (%) by MRI
- Change from baseline at Week 48 in the following markers Glucose metabolism: glycated hemoglobin (HbA1c), fasting plasma glucose, fasting C-peptide, and fasting insulin; Homeostasis Model Assessment of Insulin Resistance (HOMA-IR); Quantitative Insulin Sensitivity Check Index (QUICKI)
- Change from baseline at Week 48 in the following markers Fasting lipid profile: total cholesterol, triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), non-HDL cholesterol
- Incidence, severity, and causal relationship of AEs as reported by the Investigator, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (NCI CTCAE, v5.0)
- Change from baseline in vital signs, physical findings, ECG, and clinical laboratory results
- Incidence of local and systemic injection reactions
- Incidence of abnormal laboratory findings
- Incidence of abnormal ECG parameters
- Incidence of abnormal vital signs
- Serum concentrations of RO7204239 at specified timepoints
- PK parameters of RO7204239 including Ctrough,ss and t1/2 (if appropriate)
- Estimated PK parameters of RO7204239 using a population-PK model including AUCtau,ss, Cmax,ss, CL/F, and Vd/F
- Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 13
PRD10951785 · Product
- Active substance
- Humanised IGG1 Monoclonal Antibody Against Human Latent Myostatin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284062 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/056
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- blinding
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284060 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/054
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Blinding
Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284057 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/051
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Blinding
Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284066 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/060
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Blinding
Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284063 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/057
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- blinding
Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284058 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/052
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- blinding
Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284055 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/049
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Blinding
Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284064 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/058
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- blinding
Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284059 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/053
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Blinding
Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284056 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/050
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Blinding
Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284065 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/059
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Blinding
Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen
PRD11284061 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-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-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/055
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Blinding
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 |
|---|---|---|
| Q2q Communications Limited ORG-100041455
|
Richmond, United Kingdom | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Actigraph LLC ORG-100043702
|
Pensacola, United States | Other |
Locations
2 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruitment ended | 39 | 6 |
| Spain | Ongoing, recruitment ended | 39 | 9 |
| Rest of world
United States, United Kingdom
|
— | 156 | — |
Investigational sites
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Centrum Terapii Wspolczesnej, Ul. Przedzalniana 66, 90-338, Lodz
Etg Warszawa Sp. z o.o.
ETG Warszawa, Ul. Wynalazek 4, 02-677, Warsaw
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Centrum Badan Klinicznych PI-House, Ul. Na Zaspe 3, 80-546, Gdansk
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
CBK Piotr Napora Lekarze sp. p. Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw
Ekamed Sp. z o.o.
Centrum Medyczne EKAMED, Aleja Krasnicka 2j/u1, 20-718, Lublin
Centrum Medyczne All-Med Badania Kliniczne
CENTRUM MEDYCZNE „ALL-MED”, Ul. Henryka Sienkiewicza 23, 30-033, Cracow
Hospital General Universitario Gregorio Maranon
Servicio de Endocrinología y Nutrición, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Virgen De La Macarena
Servicio de Endocrinología y Nutrición, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinico San Carlos
Servicio de Endocrinología, Metabolismo y Nutrición, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitario Marques De Valdecilla
Servicio de Endocrinología y Nutrición, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Virgen De La Victoria
Servicio de Endocrinología y Nutrición, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Area Sanitaria De Ferrol
Servicio de Endocrinología y Nutrición, Avenida Residencia S/n, 15405, Ferrol
Hospital Universitari Vall D Hebron
Servicio de Endocrinología y Nutrición, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Nisa Sevilla Aljarafe
Unidad de Salud Metabólica, Diabetes y Obesidad, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Instituto Medico Quirurgico San Rafael S.A.
Servicio de Endocrinología y Nutrición, Poboado Nucleo Rural La Jubias 82, 15006, A Coruna
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 |
|---|---|---|---|---|---|
| Poland | 2025-07-07 | 2025-07-14 | 2025-09-15 | ||
| Spain | 2025-07-10 | 2025-07-17 | 2025-09-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2024-519561-22-00-redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Brochure_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment material_Poster_FP | N/A |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Infant F-up_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Volounteer MRI_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Volunteer MRI_FP | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-tirzepatide | N/A |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2024-519561-22-00 | N/A |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2024-519561-22-00 | N/A |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2024-519561-22-00 | N/A |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-04 | Spain | Acceptable 2025-06-05
|
2025-06-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-26 | Spain | Acceptable 2025-06-05
|
2025-09-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-20 | Spain | Acceptable 2025-06-05
|
2026-03-20 |