NCT06299098

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,005 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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)

Detailed description

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

Conditions

• Obesity

Interventions

Type	Name	Description
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	Garetosmab	Administered IV in Part B
DRUG	Semaglutide	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

Timeline

• Start date: 2024-03-13
• Primary completion: 2026-05-18
• Completion: 2026-10-30
• First posted: 2024-03-07
• Last updated: 2025-12-17

Locations

60 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study