> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-efficacy-safety-tolerability-cf719466-0a49-40f3-bc8f-c65132e7889a > Record changed: 2026-10-13 # A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity NCT06965413 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) Participants 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) Start date 2025-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) Number of sites 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Title and summary **Summary** The main aim of the study is 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 in adults with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus (DM). The study comprises of a 4-week screening period; a 48-week core treatment period, where all participants will receive tirzepatide as background treatment and will be randomized to one of the 4 treatment arms; a 24-week treatment extension period, where participants will stop treatment with tirzepatide and a 24-week post-treatment follow-up (FU) period. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Acronym** GYMINDA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Short title** A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Official title** A Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Assess Efficacy, Safety, and Tolerability of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Dates **Completion date** 2027-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **First posted** 2025-05-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Registry last updated** 2026-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Primary completion date** 2026-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Start date** 2025-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Size and sites **Actual participants** 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Participants** 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Number of sites** 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Identifiers **Registry ID** NCT06965413 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **ClinicalTrials.gov ID** NCT06965413 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Outcomes ### Primary outcomes 1. Percent Change From Baseline in Body Weight Timeframe: Baseline, Week 48 ### Secondary outcomes 1. Absolute Change From Baseline in Body Weight Timeframe: Baseline, Week 48 2. Change From Baseline in Body Mass Index (BMI) Timeframe: Baseline, Week 48 3. Change From Baseline in Waist-to-height Ratio Timeframe: Baseline, Week 48 4. Change From Baseline in Waist Circumference Timeframe: Baseline, Week 48 5. Change From Baseline in Total Body Fat Mass Measured by Dual-energy X-ray Absorptiometry (DXA) Timeframe: Baseline, Week 48 6. Change From Baseline in Total Lean Body Mass Measured by DXA Timeframe: Baseline, Week 48 7. Change From Baseline in Appendicular Lean Mass Measured by DXA at Week 48 Timeframe: Baseline, Week 48 8. Change From Baseline in Muscle Volume Measured by Magnetic Resonance Imaging (MRI) Timeframe: Baseline, Week 48 9. Change From Baseline in Muscle Fat Infiltration Measured by MRI Timeframe: Baseline, Week 48 10. Change From Baseline in Glycated Hemoglobin (HbA1C) Levels Timeframe: Baseline, Week 48 11. Change From Baseline in Fasting Plasma Glucose Levels Timeframe: Baseline, Week 48 12. Change From Baseline in Fasting C-peptide and Fasting Insulin Levels Timeframe: Baseline, Week 48 13. Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Timeframe: Baseline, Week 48 14. Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) Timeframe: Baseline, Week 48 15. Change From Baseline in Fasting Lipid Profile Timeframe: Baseline, Week 48 Fasting lipid profile includes total cholesterol, triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), non-HDL cholesterol 16. Number of Participants With Adverse Events (AEs) Timeframe: Up to approximately 100 weeks 17. Number of Participants With Local and Systemic Injection Reactions Timeframe: Up to approximately 100 weeks 18. Serum Concentrations of RO7204239 Timeframe: Up to approximately 96 weeks 19. Steady-state Trough Concentration (Ctrough,ss) of RO7204239 Timeframe: Up to approximately 96 weeks 20. Half-life (t1/2) of RO7204239 Timeframe: Up to approximately 96 weeks 21. Steady-state Area Under the Concentration-time Curve Over One Dosing Interval (AUCtau,ss) of RO7204239 Timeframe: Up to approximately 96 weeks 22. Steady-state Maximum Concentration (Cmax,ss) of RO7204239 Timeframe: Up to approximately 96 weeks 23. Apparent Clearance (CL/F) of RO7204239 Timeframe: Up to approximately 96 weeks 24. Apparent Volume of Distribution (Vd/F) of RO7204239 Timeframe: Up to approximately 96 weeks 25. Number of Participants With Anti-drug Antibodies (ADAs) to RO7204239 Timeframe: Up to approximately 96 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - BMI ≥ 30.0 kilograms per square meter (kg/m²) (additional weight-related comorbidities are not required for inclusion) - BMI ≥ 27.0 kg/m² and < 30.0 kg/m² with at least one weight-related comorbidity such as: hypertension, dyslipidemia, obstructive sleep apnea and any 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 kilograms (kg) (11 pounds \[lbs\]) within 3 months prior to screening ### Exclusion criteria - Prior history or diagnosis of DM - Presence of non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular edema - Have obesity induced by other endocrinologic disorders - Participation in unbalanced/extreme diets - Prior or planned surgical treatment for obesity - Endoscopic and/or device-based therapy for obesity or device removal within 6 months prior to screening - Have a known clinically significant gastric emptying abnormality - Have any of the following cardiovascular conditions within 6 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF) - Have evidence of significant active, uncontrolled cardiovascular, autoimmune, endocrine, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, a neurological or psychiatric condition, or a history of any neuromuscular disorder or autoimmune/inflammatory disorders that may cause muscle wasting or medical condition capable of constituting a risk when taking the study medication or interfering with the interpretation of data, as judged by the investigator at screening - Have evidence of a significant, uncontrolled endocrine abnormality - Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy - Have evidence of a significant, active autoimmune abnormality - Have anemia - Have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease - Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Sites - Pinnacle Research GroupAnniston, United States - Encompass Clinical ResearchSpring Valley, United States - K2 Medical Research-Winter GardenClermont, United States - Rophe Adult and Pediatric Medicine/SKYCRNGUnion City, United States - Accellacare of Duly Health and CareOak Lawn, United States - Rochester Clinical ResearchRochester, United States - Accellacare of SalisburySalisbury, United States - Accellacare of Piedmont HealthcareStatesville, United States - Accellacare of Wilmington, LLCWilmington, United States - Accellacare Research of Winston SalemWinston-Salem, United States - NexGen ResearchLima, United States - Accellacare of Bristol/ Internal Medicine & PediatricsBristol, United States - Accellacare of KnoxvilleKnoxville, United States - Clinical Research AssociatesNashville, United States - Texas Diabetes & Endocrinology, P.A.Austin, United States - Juno Research, LLCHouston, United States - Consano Clinical ResearchShavano Park, United States - Velocity Clinical Research (Impact Research Institute)Waco, United States - Manassas Clinical Research CenterManassas, United States - Centrum Medyczne ALL-MEDKrakow, Poland - Penta Hospials Badania Kliniczne GdanskGdansk, Poland - Ekamed sp. z o.o.Lublin, Poland - ETG WarszawaWarsaw, Poland - Universidad de Sevilla - Hospital Universitario Virgen MacarenaSeville, Spain - Instituto De Investigacion Marques De Valdecilla (IDIVAL)Santander, Spain And 10 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## References ### Other registry identifiers - 2024-519561-22-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06965413) ## Related records ### Drugs (2) - [Emugrobart](https://trialight.com/data/asset/emugrobart-171b8e9a-b126-43a2-8a0d-92998cda5192.md) - [Tirzepatide](https://trialight.com/data/asset/tirzepatide-eed85871-eb9c-4712-9102-badfdd99a720.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition ### Targets (2) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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