A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss

Obesity Clinical Trial

— COURAGE  

Official title:

A Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06299098
• Other study ID #: R1033-OB-2288
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 13, 2024
• Est. completion date: June 24, 2026

Study information

• Verified date: March 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). Part A of the study, the sponsor is only researching trevogrumab. Part B of the study the sponsor is researching trevogrumab, garetosmab, and Wegovy either alone or in different combinations with each other. Part A of the study is focused on healthy participants. Part B of the study is focused on participants with obesity. The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B of the study is to see how safe and effective the study drug is when combined with Wegovy. Parts A and B of the study are looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Description:

Part A Healthy Volunteers Part B (starts after treatment for Part A has completed) Participants with Obesity

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 624
• Est. completion date: June 24, 2026
• Est. primary completion date: June 24, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Key Inclusion Criteria Part A

1. Male or female participants age =18 to =55 years of age at the time of screening

2. BMI =18 and =32 kg/m2, at the screening visit Part B

3. Male or female participants =18 to =80 years of age at the time of screening

4. BMI =30 kg/m2

5. History of 1 or more self-reported unsuccessful dietary attempts to lose weight Key Exclusion Criteria

1. History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted

2. Previous bariatric surgery or planned bariatric surgery

3. History of hypertrophic cardiomyopathy

4. Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy

5. Any malignancy in the past 5 years prior to screening (except for nonmelanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years prior to screening)

6. History of poorly controlled hypertension, as defined in the protocol

7. Have a history of any other condition (such as known drug abuse, alcohol abuse, diagnosed eating disorder, or a severe mental illness) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol

8. Have history of use of marijuana/tetrahydrocannabinol (THC) within 3 months of enrollment and are unwilling to abstain from marijuana/THC use during the trial

9. Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc) Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Trevogrumab-Part A
Administered IV or SC in Part A
• Trevogrumab-Part B
Administered SC in Part B
• Garetosmab
Administered IV in Part B
• Semaglutide
Administered SC in Part B
• Matching Placebo-Part A
Administered IV or SC in Part A
• Matching Placebo-Trevogrumab
Administered SC in Part B
• Matching Placebo-Garetosmab
Administered IV in Part B

Locations

Country	Name	City	State
United States	ProSciento	Chula Vista	California
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Accellacare of Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)	Part A	Baseline to week 7
Primary	Severity of TEAEs	Part A	Baseline to week 7
Primary	Percent body weight change	Part B	Baseline to week 26
Primary	Percent change in total fat mass	Part B	Baseline to week 26
Secondary	Concentrations of trevogrumab in serum over time	Part A and Part B	Up to 75 weeks
Secondary	Percent body weight change	Part B	Baseline to week 52
Secondary	Percent change in total fat mass	Part B	Baseline to week 52
Secondary	Percent change in total lean mass	Part B	Baseline to week 26
Secondary	Change in waist circumference (cm)	Part B	Baseline to week 26
Secondary	Percent change in body weight	Part B	Baseline to week 52
Secondary	Percent change in total lean mass	Part B	Baseline to week 52
Secondary	Percent change in regional measurements of body composition	Part B	Baseline to week 26
Secondary	Percent change in gynoid fat mass	Part B	Baseline to week 26
Secondary	Change in total lean mass:total fat mass ratio	Part B	Baseline to week 26
Secondary	Proportion of weight loss attributable to fat mass loss	Part B	Baseline to week 26
Secondary	Percent change in android (central) fat mass	Part B	Baseline to week 26
Secondary	Percent change in thigh muscle volume (TMV)	Part B	Baseline to week 26
Secondary	Body weight reduction of =5%	Part B	Baseline to week 26
Secondary	Body weight reduction of =10%	Part B	Baseline to week 26
Secondary	Body weight reduction of =15%	Part B	Baseline to week 26
Secondary	Body weight reduction of =20%	Part B	Baseline to week 26
Secondary	Body weight reduction of =25%	Part B	Baseline to week 26
Secondary	Percent change in fasting serum triglycerides	Part B	Baseline to week 26
Secondary	Percent change in total cholesterol	Part B	Baseline to week 26
Secondary	Percent change in Apolipoprotein B (Apo B)	Part B	Baseline to week 26
Secondary	Percent change in low-density lipoprotein cholesterol (LDL-C)	Part B	Baseline to week 26
Secondary	Change in physical function domain (5 items) score of Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQoLLite- CT)	Part B IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assesses the 'physical function score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.	Baseline to week 26
Secondary	Change in physical functioning domain score of SF-36	Part B Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	Baseline to week 26
Secondary	Concentrations of garetosmab in serum over time	Part B	Up to 75 weeks
Secondary	Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time	Part B	Up to 75 weeks
Secondary	Titer of ADAs to trevogrumab after repeated doses over time	Part B	Up to 75 weeks
Secondary	Incidence of ADAs to garetosmab after repeated doses over time	Part B	Up to 75 weeks
Secondary	Titer of ADAs to garetosmab after repeated doses over time	Part B	Up to 75 weeks
Secondary	Incidence of TEAEs	Part B	Up to 75 weeks
Secondary	Severity of TEAEs	Part B	Up to 75 weeks