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, Fat Loss, and Lean Mass Preservation
NCT06299098 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1005
Last updated 2026-05-08
Summary
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)
Conditions
Interventions
- DRUG
-
Trevogrumab-Part A
Administered IV or SC in Part A
- DRUG
-
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
- DRUG
-
Administered IV in Part B
- DRUG
-
Administered SC in Part B and Part C
- DRUG
-
Matching Placebo-Part A
Administered IV or SC in Part A
- DRUG
-
Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
- DRUG
-
Matching Placebo-Garetosmab
Administered IV in Part B
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-13
- Primary Completion
- 2026-05-18
- Completion
- 2026-10-30
- FDA Drug
- Yes
Countries
- United States
- Puerto Rico
Study Locations
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