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NCT Number: NCT06965413

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

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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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centrum Medyczne ALL-MED, Krakow, Lesser Poland Voivodeship, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RO7204239

Drug

RO7204239 or matching placebo will be administered as per the schedule specified in the arms.

RO7204239 Matching Placebo

Drug

RO7204239 matching placebo will be administered as per the schedule specified in the arm.

Tirzepatide

Drug

Tirzepatide will be administered as per the schedule specified in the arms.

Primary outcomes

  1. Percent Change From Baseline in Body Weight

    Time frame: Baseline, Week 48

Secondary outcomes

  1. Absolute Change From Baseline in Body Weight

    Time frame: Baseline, Week 48

  2. Change From Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 48

  3. Change From Baseline in Waist-to-height Ratio

    Time frame: Baseline, Week 48

  4. Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 48

  5. Change From Baseline in Total Body Fat Mass Measured by Dual-energy X-ray Absorptiometry (DXA)

    Time frame: Baseline, Week 48

  6. Change From Baseline in Total Lean Body Mass Measured by DXA

    Time frame: Baseline, Week 48

  7. Change From Baseline in Appendicular Lean Mass Measured by DXA at Week 48

    Time frame: Baseline, Week 48

  8. Change From Baseline in Muscle Volume Measured by Magnetic Resonance Imaging (MRI)

    Time frame: Baseline, Week 48

  9. Change From Baseline in Muscle Fat Infiltration Measured by MRI

    Time frame: Baseline, Week 48

  10. Change From Baseline in Glycated Hemoglobin (HbA1C) Levels

    Time frame: Baseline, Week 48

  11. Change From Baseline in Fasting Plasma Glucose Levels

    Time frame: Baseline, Week 48

  12. Change From Baseline in Fasting C-peptide and Fasting Insulin Levels

    Time frame: Baseline, Week 48

  13. Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: Baseline, Week 48

  14. Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI)

    Time frame: Baseline, Week 48

  15. Change From Baseline in Fasting Lipid Profile

    Time frame: 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)

    Time frame: Up to approximately 100 weeks

  17. Number of Participants With Local and Systemic Injection Reactions

    Time frame: Up to approximately 100 weeks

  18. Serum Concentrations of RO7204239

    Time frame: Up to approximately 96 weeks

  19. Steady-state Trough Concentration (Ctrough,ss) of RO7204239

    Time frame: Up to approximately 96 weeks

  20. Half-life (t1/2) of RO7204239

    Time frame: Up to approximately 96 weeks

  21. Steady-state Area Under the Concentration-time Curve Over One Dosing Interval (AUCtau,ss) of RO7204239

    Time frame: Up to approximately 96 weeks

  22. Steady-state Maximum Concentration (Cmax,ss) of RO7204239

    Time frame: Up to approximately 96 weeks

  23. Apparent Clearance (CL/F) of RO7204239

    Time frame: Up to approximately 96 weeks

  24. Apparent Volume of Distribution (Vd/F) of RO7204239

    Time frame: Up to approximately 96 weeks

  25. Number of Participants With Anti-drug Antibodies (ADAs) to RO7204239

    Time frame: Up to approximately 96 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: GYMINDA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 11, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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