GYMINDA

Active not recruitingPhase 2

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

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

Lead sponsor

Hoffmann-La Roche

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

285

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06965413

Org study IDBC45538

Secondary ID2024-519561-22-00EU Trial Number

Timeline

Milestones

Study start2025-05-05actual

Study first posted2025-05-11actual

Last update posted2026-05-13actual

Primary completion2026-08-24estimated

Study completion2027-07-23estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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)

Endpoints (26)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Safety / tolerability / PK

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

10 endpoints

Primary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Change From Baseline in Body Weight

Time frame:Baseline, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 48

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist-to-height Ratio

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 48

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 48

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total Lean Body Mass Measured by DXA

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Muscle Fat Infiltration Measured by MRI

Time frame:Baseline, Week 48

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Secondary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1C) Levels

Time frame:Baseline, Week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose Levels

Time frame:Baseline, Week 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

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

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 48

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 48

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile

Time frame:Baseline, Week 48

change from baseline, improvement

Safety / tolerability / PK

10 endpoints

Secondary/protocol endpoint

Number of Participants With Adverse Events (AEs)

Time frame:Up to approximately 100 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Local and Systemic Injection Reactions

Time frame:Up to approximately 100 weeks

event count, event

Secondary/protocol endpoint

Serum Concentrations of RO7204239

Time frame:Up to approximately 96 weeks

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Up to approximately 96 weeks

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Half-life (t1/2) of RO7204239

Time frame:Up to approximately 96 weeks

Half-life

descriptive

Secondary/protocol endpoint

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

Time frame:Up to approximately 96 weeks

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Up to approximately 96 weeks

Cmax

concentration, descriptive

Secondary/protocol endpoint

Apparent Clearance (CL/F) of RO7204239

Time frame:Up to approximately 96 weeks

descriptive

Secondary/protocol endpoint

Apparent Volume of Distribution (Vd/F) of RO7204239

Time frame:Up to approximately 96 weeks

descriptive

Secondary/protocol endpoint

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

Time frame:Up to approximately 96 weeks

Immunogenicity (ADA)

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.