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 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing the safety and effectiveness of trevogrumab alone or combined with garetosmab, along with semaglutide, in adults with obesity to help with weight loss, fat loss, and preserving muscle mass.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 1,005 people

Who can join Ages 18–80 · all sexes Healthy volunteers accepted.

Timeline Started 2024-03 · est. completion 2026-10

Where 60 sites · Puerto Rico, United States

What this study is testing ClinicalTrials.gov NCT06299098 ↗

Description as written by the study sponsor.

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)

Treatments tested

Trevogrumab-Part A also known as REGN1033, GDF8 Drug

Administered IV or SC in Part A
Trevogrumab-Part B and Part C also known as REGN1033, GDF8 Drug

Administered SC in Part B, Part C
Garetosmab also known as REGN2477, Activin A Drug

Administered IV in Part B
Semaglutide also known as Wegovy® Drug

Administered SC in Part B and Part C
Matching Placebo-Part A Drug

Administered IV or SC in Part A
Matching Placebo-Trevogrumab Drug

Administered SC in Part B and Part C
Matching Placebo-Garetosmab Drug

Administered IV in Part B

Main thing measured	Incidence of treatment-emergent adverse events (TEAEs)
Sponsor	Regeneron Pharmaceuticals
Conditions studied	Obesity
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06299098 ↗