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Phase II: Emugrobart for overweight/obesity (GYMINDA study)

Clinical Trial Overview

The Phase 2 GYMINDA study is a study to assess efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Emugrobart (RO7204239) in combination with Tirzepatide in participants who are obese or overweight with at least one weight-related comorbidity [NCT06965413]

Objective

The purpose of this study is to assess the effect of emugrobart in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment in adults who are obese or overweight with at least one weight-related comorbidity, but without diabetes mellitus. 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.

Trial Design

GYMINDA: Phase 2 Double-blind, Randomized, Placebo-controlled Study Design in patients with obesity or overweight

Primary Endpoints

Percent change in body weight from Baseline at Week 48

Secondary Endpoints

Absolute Change From Baseline in Body Weight [Time Frame: Baseline, Week 48]
Change From Baseline in Body Mass Index (BMI) [Time Frame: Baseline, Week 48]
Change From Baseline in Waist-to-height Ratio [Time Frame: Baseline, Week 48]
Change From Baseline in Waist Circumference [Time Frame: Baseline, Week 48]
Change From Baseline in Total Body Fat Mass Measured by Dual-energy X-ray Absorptiometry (DXA) [Time Frame: Baseline, Week 48]
Change From Baseline in Total Lean Body Mass Measured by DXA [Time Frame: Baseline, Week 48]
Change From Baseline in Appendicular Lean Mass Measured by DXA at Week 48 [Time Frame: Baseline, Week 48]
Change From Baseline in Muscle Volume Measured by Magnetic Resonance Imaging (MRI) [Time Frame: Baseline, Week 48]
Change From Baseline in Muscle Fat Infiltration Measured by MRI [Time Frame: Baseline, Week 48]
Change From Baseline in Glycated Hemoglobin (HbA1C) Levels [Time Frame: Baseline, Week 48]
Change From Baseline in Fasting Plasma Glucose Levels [Time Frame: Baseline, Week 48]
Change From Baseline in Fasting C-peptide and Fasting Insulin Levels [Time Frame: Baseline, Week 48]
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [Time Frame: Baseline, Week 48]
Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) [Time Frame: Baseline, Week 48]
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
Number of Participants With Adverse Events (AEs) [Time Frame: Up to approximately 100 weeks]
Number of Participants With Local and Systemic Injection Reactions [Time Frame: Up to approximately 100 weeks]
Serum Concentrations of RO7204239 [Time Frame: Up to approximately 96 weeks]
Steady-state Trough Concentration (Ctrough,ss) of RO7204239 [Time Frame: Up to approximately 96 weeks]
Half-life (t1/2) of RO7204239 [Time Frame: Up to approximately 96 weeks]
Steady-state Area Under the Concentration-time Curve Over One Dosing Interval (AUCtau,ss) of RO7204239 [Time Frame: Up to approximately 96 weeks]
Steady-state Maximum Concentration (Cmax,ss) of RO7204239 [Time Frame: Up to approximately 96 weeks]
Apparent Clearance (CL/F) of RO7204239 [Time Frame: Up to approximately 96 weeks]
Apparent Volume of Distribution (Vd/F) of RO7204239 [Time Frame: Up to approximately 96 weeks]
Number of Participants With Anti-drug Antibodies (ADAs) to RO7204239 [Time Frame: Up to approximately 96 weeks]

Web site. https://clinicaltrials.gov/study/NCT06965413#study-overview. ClinicalTrials.gov identifier: NCT06965413. Updated 08282025. Accessed 08282025

Emugrobart

Other names: Anti-Latent Myostatin (LM), GYM329, RO7204239, RG6237
Target: Inhibit LM to prevent conversion to mature myostatin

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QUICK LINKS

Clinical Trial Overview

Inclusion and Exclusion Criteria

Enrollment and Resources

View on ClinicalTrials.gov

Inclusion and Exclusion Criteria

Key Inclusion Criteria

Key Exclusion Criteria

Male or female subjects ≥ 18 years of age at the time of informed consent
Participants must have at Screening:
- BMI ≥30.0 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 kg (11 lbs) within 3 months prior to Screening

Prior history or diagnosis of diabetes mellitus
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)

Web site. https://clinicaltrials.gov/study/NCT06965413 Updated May 11, 2025. Accessed May 16, 2025.

Enrollment & Resources

Enrollment

For more information on eligibility criteria, view the study or reach out to our team.

Web

ClinicalTrials.gov
Identifier: NCT06965413

Phone

1-888-662-6728
(US and Canada)

Email

[email protected]

Clinical Trial Site Locations

Clinical Trial Site Locations

For more information on recruitment status, or where the study is being conducted

Visit ClinicalTrials.gov

Information is consistent with ClinicalTrials.gov as of May 16, 2025. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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ADA
anti-drug antibody
BMI
Body mass index
DXA
Dual-energy X-ray Absorptiometry
HbA1c
Hemoglobin A1c
R
Randomization
SC
Subcutaneous