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
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
285
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Lead sponsor
Hoffmann-La Roche
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Start date
2025-05-05
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Number of sites
35
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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.
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Acronym
GYMINDA
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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
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-03-31
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First posted
2025-05-11
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Registry last updated
2026-08-11
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Primary completion date
2026-08-22
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Start date
2025-05-05
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Actual participants
285
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Participants
285
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
35
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Hoffmann-La Roche
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06965413
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ClinicalTrials.gov ID
NCT06965413
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percent Change From Baseline in Body Weight

    Timeframe: Baseline, Week 48

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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)
Sources for eligibility
clinicaltrials.gov

  • 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
clinicaltrials.gov

Other registry identifiers

  • 2024-519561-22-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)