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HomeTrials › NCT06299098

Obesity & weight · Phase 2 · Active, not recruiting

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 · Sponsor: Regeneron Pharmaceuticals

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Trevogrumab-Part A, Trevogrumab-Part B and Part C, Garetosmab, Semaglutide, Matching Placebo-Part A, Matching Placebo-Trevogrumab, Matching Placebo-Garetosmab for obesity.

Who can joinAll sexes, 18 Years – 80 Years
Healthy volunteersAccepted
What you'd takeTrevogrumab-Part A, Trevogrumab-Part B and Part C, Garetosmab, Semaglutide, Matching Placebo-Part A, Matching Placebo-Trevogrumab, Matching Placebo-Garetosmab
Study length~2.2 years overall
Planned participants1,005
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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)

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Key Inclusion Criteria Part A 1. Male or female participants age ≥18 to ≤55 years of age at the time of screening 2. BMI ≥18 and ≤32 kg/m2, at the screening visit Part B and Part C 3. Male or female participants ≥18 to ≤80 years of age at the time of screening 4. BMI ≥30 kg/m2, at the screening visit 5. History of 1 or more self-reported unsuccessful dietary attempts to lose weight Key Exclusion Criteria 1. History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted 2. Previous bariatric surgery or planned bariatric surgery 3. History of hypertrophic cardiomyopathy 4. Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy 5. Any malignancy in the past 5 years prior to screening (except for nonmelanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years prior to screening) 6. History of poorly controlled hypertension, as defined in the protocol 7. Have a history of any other condition (such as known drug abuse, alcohol abuse, diagnosed eating disorder, or a severe mental illness) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol 8. Have history of use of marijuana/tetrahydrocannabinol (THC) within 90 days prior to Visit 1 of enrollment and are unwilling to abstain from marijuana/THC use during the trial 9. Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc) Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study sites by state

Alabama

  • Pinnacle Research Group — Anniston
  • Cullman Clinical Trials — Cullman

Arizona

  • Foothills Research Center Cct Research — Phoenix

California

  • Anaheim Clinical Trials — Anaheim
  • ProSciento — Chula Vista
  • Valiance Clinical Research- Huntington Park — Huntington Park
  • Velocity, San Diego — La Mesa
  • Northern California Research — Sacramento
  • Acclaim Clinical Research — San Diego
  • Metabolic Institute of America — Tarzana
  • Valiance Clinical Research — Tarzana

Florida

  • Southwest General Healthcare Center — Fort Myers
  • Westside Center for Clinical Research — Jacksonville
  • Jacksonville Center for Clinical Research — Jacksonville
  • IMA Clinical Research St. Petersburg — St. Petersburg
  • Precision Clinical Research, LLC — Sunrise
  • Clinical Research of West Florida, Inc. — Tampa
  • Clinical Research of Central Florida - Bond Clinic — Winter Haven

Georgia

  • Center for Advanced Research and Education — Gainesville
  • Balanced Life Health Care Solutions — Lawrenceville
  • North Georgia Clinical Research — Woodstock

Hawaii

  • East-West Medical Research Institute — Honolulu

Idaho

  • Elite Clinical Trials LLLP — Blackfoot

Illinois

  • Prairie Education and Research Cooperative (PERC) — Springfield

Indiana

  • The South Bend Clinic Center for Research — South Bend

Kansas

  • Cotton O'Neil Clinical Research Center — Topeka

Kentucky

  • L-MARC Research Center — Louisville

Louisiana

  • Tandem Clinical Research GI, LLC — Marrero
  • IMA Clinical Research Monroe - Armand — Monroe

Minnesota

  • Mayo Clinic — Rochester

Mississippi

  • Prime Health and Wellness Clinic — Fayette
  • Olive Branch Family Medical Center — Olive Branch
  • Sky Integrative Medical Center Skycrng — Ridgeland

Missouri

  • Jefferson City Medical Group — Jefferson City
  • Clinvest Research — Springfield

Montana

  • Mercury Street Medical Group, PLLC — Butte

New Jersey

  • Hassman Research Institute — Berlin

North Carolina

  • Accellacare Clinical Research, Raleigh Medical Group — Raleigh
  • Accellacare of Salisbury — Salisbury
  • Accellacare of Piedmont, Piedmont Healthcare — Statesville
  • Pmg Research of Wilmington Llc — Wilmington
  • PMG Research of Winston-Salem, LLC — Winston-Salem
  • Javara Incorporated at Wake Forest University Health Sciences — Winston-Salem

Ohio

  • Velocity Clinical Research Inc. — Cincinnati

Oklahoma

  • AMR Norman — Norman

Pennsylvania

  • Altoona Center for Clinical Research — Duncansville

South Carolina

  • Tribe Clinical Research Llc — Greenville
  • PMG Research of Charleston — Mt. Pleasant

Tennessee

  • Pmg Research of Bristol — Bristol
  • Chattanooga Medical Research — Chattanooga
  • PMG Research of Knoxville - Merchant Drive — Knoxville
  • PMG Research of Knoxville - Emory Road — Knoxville

Texas

  • Velocity Clinical Research Dallas — Dallas
  • Medresearch Inc — El Paso
  • Valley Institute of Research — Fort Worth
  • Consano Clinical Research — Shavano Park

Virginia

  • Charlottesville Medical Research — Charlottesville
  • Health Research of Hampton Roads, Inc. — Newport News

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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