Trevogrumab + Garetosmab + Semaglutide for Obesity

(COURAGE Trial)

Recruiting at 59 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Regeneron Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). This study will be done in 3 parts, Part A, Part B, and Part C where different study drugs will be tested. Part A of the study is focused on healthy participants. Part B and C 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 and Part C of the study is to see how safe and effective the study drug is when combined with Wegovy. Parts A, B, and C 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)

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

This trial is for adults aged 18-55 with a BMI of 18-32 (Part A), and those aged 18-80 with obesity, defined as a BMI over 30 (Part B). Participants should have tried to lose weight unsuccessfully before. It's not clear what excludes someone from joining.

Inclusion Criteria

You have been diagnosed with Nonalcoholic Steatohepatitis

I am between 18 and 55 years old with a BMI between 18 and 32.

I am between 18 and 80 years old, have a BMI of 30 or more, and have tried to lose weight through diet without success.

Exclusion Criteria

I haven't had any cancer except for non-spreading skin cancer in the last 5 years.

I have a history of a neuromuscular disorder.

I have had or am planning to have weight loss surgery.

Treatment Details

Interventions

• Garetosmab (Monoclonal Antibodies)
• Trevogrumab (Monoclonal Antibodies)

Trial Overview The study tests trevogrumab alone or combined with garetosmab and semaglutide in two parts: Part A focuses on safety in healthy individuals; Part B examines effectiveness for weight loss in obese participants using various drug combinations.

Participant Groups

Group I: Trevogrumab Experimental Treatment 1 Intervention

Part A Randomized 1:1

Group II: Arm D1 Experimental Treatment 3 Interventions

Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Group III: Arm D0 Experimental Treatment 4 Interventions

Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Group IV: Arm C1 Experimental Treatment 3 Interventions

Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Group V: Arm C0 Experimental Treatment 4 Interventions

Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Group VI: Arm B1 Experimental Treatment 3 Interventions

Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Group VII: Arm B0 Experimental Treatment 4 Interventions

Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Group VIII: Arm A1 Experimental Treatment 4 Interventions

Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1

Group IX: Arm A0 Experimental Treatment 3 Interventions

Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Group X: Arm 3 Experimental Treatment 3 Interventions

Part C Sema and SC moderate dose trevo Randomized 1:2:2

Group XI: Arm 2 Experimental Treatment 3 Interventions

Part C Sema and SC low dose trevo Randomized 1:2:2

Group XII: Arm 1 Experimental Treatment 2 Interventions

Part C Sema and SC placebo Randomized 1:2:2

Group XIII: Placebo Placebo Group 1 Intervention

Part A Randomized 1:1

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School