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Clinical Trial NCT06965413 (GYMINDA) for Obesity, Overweight, Overweight With One Weight Related Comorbidity is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Hoffmann-La RocheA 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 (GYMINDA) Phase 2 285 Randomized
Clinical Trial NCT06965413 (GYMINDA) is designed to study Treatment for Obesity, Overweight, Overweight With One Weight Related Comorbidity. It is a Phase 2 interventional study that is active, not recruiting, having started on May 5, 2025, with plans to enroll 285 participants. Led by Hoffmann-La Roche, it is expected to complete by July 23, 2027. The latest data from ClinicalTrials.gov was last updated on February 12, 2026.
Brief 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 participant...Show More
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
Conditions
ObesityOverweightOverweight With One Weight Related ComorbidityOther Study IDs
- GYMINDA
- BC45538
- 2024-519561-22-00 (Registry Identifier) (EU Trial Number)
NCT ID Number
Start Date (Actual)
2025-05-05
Last Update Posted
2026-02-12
Completion Date (Estimated)
2027-07-23
Enrollment (Estimated)
285
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorPlacebo + Tirzepatide Participants will receive RO7204239 matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for the core treatment period of 48 weeks and the treatment extension period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, every week (QW) during the core treatment period of 48 weeks. | RO7204239 RO7204239 or matching placebo will be administered as per the schedule specified in the arms. RO7204239 Matching Placebo RO7204239 matching placebo will be administered as per the schedule specified in the arm. Tirzepatide Tirzepatide will be administered as per the schedule specified in the arms. |
ExperimentalRO7204239 low dose + Tirzepatide Participants will receive RO7204239, low dose, SC, Q4W for the core treatment period of 48 weeks. During the treatment extension period participants will receive placebo for the period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks. | RO7204239 RO7204239 or matching placebo will be administered as per the schedule specified in the arms. Tirzepatide Tirzepatide will be administered as per the schedule specified in the arms. |
ExperimentalRO7204239 medium dose + Tirzepatide Participants will receive RO7204239, medium dose, SC, Q4W for the core treatment period of 48 weeks. During the treatment extension period participants will receive placebo for the period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks. | RO7204239 RO7204239 or matching placebo will be administered as per the schedule specified in the arms. Tirzepatide Tirzepatide will be administered as per the schedule specified in the arms. |
ExperimentalRO7204239 high dose + Tirzepatide Participants will receive RO7204239, high dose, SC, Q4W along with tirzepatide, given as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks. During the treatment extension period participants will be randomized to receive RO7204239 or matching placebo, SC, Q4W for 24 weeks. | RO7204239 RO7204239 or matching placebo will be administered as per the schedule specified in the arms. Tirzepatide Tirzepatide will be administered as per the schedule specified in the arms. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Percent Change From Baseline in Body Weight | Baseline, Week 48 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Absolute Change From Baseline in Body Weight | Baseline, Week 48 | |
Change From Baseline in Body Mass Index (BMI) | Baseline, Week 48 | |
Change From Baseline in Waist-to-height Ratio | Baseline, Week 48 | |
Change From Baseline in Waist Circumference | Baseline, Week 48 | |
Change From Baseline in Total Body Fat Mass Measured by Dual-energy X-ray Absorptiometry (DXA) | Baseline, Week 48 | |
Change From Baseline in Total Lean Body Mass Measured by DXA | Baseline, Week 48 | |
Change From Baseline in Appendicular Lean Mass Measured by DXA at Week 48 | Baseline, Week 48 | |
Change From Baseline in Muscle Volume Measured by Magnetic Resonance Imaging (MRI) | Baseline, Week 48 | |
Change From Baseline in Muscle Fat Infiltration Measured by MRI | Baseline, Week 48 | |
Change From Baseline in Glycated Hemoglobin (HbA1C) Levels | Baseline, Week 48 | |
Change From Baseline in Fasting Plasma Glucose Levels | Baseline, Week 48 | |
Change From Baseline in Fasting C-peptide and Fasting Insulin Levels | Baseline, Week 48 | |
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Baseline, Week 48 | |
Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) | Baseline, Week 48 | |
Change From Baseline in Fasting Lipid Profile | Fasting lipid profile includes total cholesterol, triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), non-HDL cholesterol | Baseline, Week 48 |
Number of Participants With Adverse Events (AEs) | Up to approximately 100 weeks | |
Number of Participants With Local and Systemic Injection Reactions | Up to approximately 100 weeks | |
Serum Concentrations of RO7204239 | Up to approximately 96 weeks | |
Steady-state Trough Concentration (Ctrough,ss) of RO7204239 | Up to approximately 96 weeks | |
Half-life (t1/2) of RO7204239 | Up to approximately 96 weeks | |
Steady-state Area Under the Concentration-time Curve Over One Dosing Interval (AUCtau,ss) of RO7204239 | Up to approximately 96 weeks | |
Steady-state Maximum Concentration (Cmax,ss) of RO7204239 | Up to approximately 96 weeks | |
Apparent Clearance (CL/F) of RO7204239 | Up to approximately 96 weeks | |
Apparent Volume of Distribution (Vd/F) of RO7204239 | Up to approximately 96 weeks | |
Number of Participants With Anti-drug Antibodies (ADAs) to RO7204239 | Up to approximately 96 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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)
Hoffmann-La Roche289 active studies to exploreNo contact data.
35 Study Locations in 4 Countries
Alabama
Pinnacle Research Group, Anniston, Alabama, 36207, United States
California
Encompass Clinical Research, Spring Valley, California, 91978, United States
Florida
K2 Medical Research-Winter Garden, Clermont, Florida, 34711, United States
Georgia
Rophe Adult and Pediatric Medicine/SKYCRNG, Union City, Georgia, 30291, United States
Illinois
Accellacare of Duly Health and Care, Oak Lawn, Illinois, 60453, United States
New York
Rochester Clinical Research, Rochester, New York, 14609, United States
North Carolina
Accellacare of Salisbury, Salisbury, North Carolina, 28144, United States
Accellacare of Piedmont Healthcare, Statesville, North Carolina, 28625, United States
Accellacare of Wilmington, LLC, Wilmington, North Carolina, 28401, United States
Accellacare Research of Winston Salem, Winston-Salem, North Carolina, 27103, United States
Ohio
NexGen Research, Lima, Ohio, 45801, United States
Tennessee
Accellacare of Bristol/ Internal Medicine & Pediatrics, Bristol, Tennessee, 37620, United States
Accellacare of Knoxville, Knoxville, Tennessee, 37912, United States
Clinical Research Associates, Nashville, Tennessee, 37203, United States
Texas
Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78731, United States
Juno Research, LLC, Houston, Texas, 77040, United States
Consano Clinical Research, Shavano Park, Texas, 78231, United States
Velocity Clinical Research (Impact Research Institute), Waco, Texas, 76710, United States
Virginia
Manassas Clinical Research Center, Manassas, Virginia, 20110, United States
Pomeranian Voivodeship
Centrum Badan Klinicznych PI-House sp. z o.o., Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne ALL-MED, Krakow, 30-033, Poland
Ekamed sp. z o.o., Lublin, 20-718, Poland
ETG Warszawa, Warsaw, 02-677, Poland
Barcelona
Universidad de Sevilla - Hospital Universitario Virgen Macarena, Seville, Barcelona, 41009, Spain
Cantabria
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, 39008, Spain
Granada
Hospital Vithas Nisa Sevilla, Castilleja de la Cuesta, Granada, 41950, Spain
LA Coruna
Hospital San Rafael A Coruna, A Coruña, LA Coruna, 15006, Spain
Hospital Universitari Vall d'Hebron, Barcelona, 08035, Spain
Hospital Universitario Virgen de la Victoria, Málaga, 29010, Spain
Lancashire
Fylde Coast Clinical Research at Layton Medical Centre, Blackpool, Lancashire, FY3 7EN, United Kingdom
Leicestershire
University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH), Leicester, Leicestershire, LE5 4PW, United Kingdom
Yorkshire
Accellacare Yorkshire, Shipley, Yorkshire, BD18 3SA, United Kingdom
Accellacare Warwickshire, Coventry, CV3 4FJ, United Kingdom
Accellacare North London, Northwood, HA6 2RN, United Kingdom
Accellacare South London, Orpington, BR5 3QG, United Kingdom