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ACTIVE NOT RECRUITING
NCT06299098
PHASE2

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1005

Start Date

2024-03-13

Completion Date

2026-10-30

Last Updated

2025-12-17

Healthy Volunteers

Yes

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

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

Locations (60)

Pinnacle Research Group

Anniston, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

Foothills Research Center Cct Research

Phoenix, Arizona, United States

Anaheim Clinical Trials

Anaheim, California, United States

ProSciento

Chula Vista, California, United States

Valiance Clinical Research- Huntington Park

Huntington Park, California, United States

Velocity, San Diego

La Mesa, California, United States

Northern California Research

Sacramento, California, United States

Acclaim Clinical Research

San Diego, California, United States

Metabolic Institute of America

Tarzana, California, United States

Valiance Clinical Research

Tarzana, California, United States

Southwest General Healthcare Center

Fort Myers, Florida, United States

Westside Center for Clinical Research

Jacksonville, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

IMA Clinical Research St. Petersburg

St. Petersburg, Florida, United States

Precision Clinical Research, LLC

Sunrise, Florida, United States

Clinical Research of West Florida, Inc.

Tampa, Florida, United States

Clinical Research of Central Florida - Bond Clinic

Winter Haven, Florida, United States

Center for Advanced Research and Education

Gainesville, Georgia, United States

Balanced Life Health Care Solutions

Lawrenceville, Georgia, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Elite Clinical Trials LLLP

Blackfoot, Idaho, United States

Prairie Education and Research Cooperative (PERC)

Springfield, Illinois, United States

The South Bend Clinic Center for Research

South Bend, Indiana, United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

L-MARC Research Center

Louisville, Kentucky, United States

Tandem Clinical Research GI, LLC

Marrero, Louisiana, United States

IMA Clinical Research Monroe - Armand

Monroe, Louisiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Prime Health and Wellness Clinic

Fayette, Mississippi, United States

Olive Branch Family Medical Center

Olive Branch, Mississippi, United States

Sky Integrative Medical Center Skycrng

Ridgeland, Mississippi, United States

Jefferson City Medical Group

Jefferson City, Missouri, United States

Clinvest Research

Springfield, Missouri, United States

Mercury Street Medical Group, PLLC

Butte, Montana, United States

Hassman Research Institute

Berlin, New Jersey, United States

Accellacare Clinical Research, Raleigh Medical Group

Raleigh, North Carolina, United States

Accellacare of Salisbury

Salisbury, North Carolina, United States

Accellacare of Piedmont, Piedmont Healthcare

Statesville, North Carolina, United States

Pmg Research of Wilmington Llc

Wilmington, North Carolina, United States

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

Javara Incorporated at Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Velocity Clinical Research Inc.

Cincinnati, Ohio, United States

AMR Norman

Norman, Oklahoma, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Tribe Clinical Research Llc

Greenville, South Carolina, United States

PMG Research of Charleston

Mt. Pleasant, South Carolina, United States

Pmg Research of Bristol

Bristol, Tennessee, United States

Chattanooga Medical Research

Chattanooga, Tennessee, United States

PMG Research of Knoxville - Merchant Drive

Knoxville, Tennessee, United States

PMG Research of Knoxville - Emory Road

Knoxville, Tennessee, United States

Velocity Clinical Research Dallas

Dallas, Texas, United States

Medresearch Inc

El Paso, Texas, United States

Valley Institute of Research

Fort Worth, Texas, United States

Consano Clinical Research

Shavano Park, Texas, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

Health Research of Hampton Roads, Inc.

Newport News, Virginia, United States

Fundacion de Investigacion (FDI) Clinical Research

San Juan, Puerto Rico

PRCCI Clinical Research Center

San Juan, Puerto Rico