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 and Fat Loss

Last updated: November 21, 2024
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

2

Condition

Diabetes Prevention

Obesity

Treatment

Garetosmab

Matching Placebo-Garetosmab

Trevogrumab-Part A

Clinical Study ID

NCT06299098
R1033-OB-2288
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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)

Eligibility Criteria

Inclusion

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

  1. Male or female participants ≥18 to ≤80 years of age at the time of screening

  2. BMI ≥30 kg/m2, at the screening visit

  3. 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 Design

Total Participants: 999
Treatment Group(s): 8
Primary Treatment: Garetosmab
Phase: 2
Study Start date:
March 13, 2024
Estimated Completion Date:
August 17, 2026

Study Description

Part A Healthy Volunteers

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

Connect with a study center

  • FDI Clinical Research

    San Juan, 00927
    Puerto Rico

    Site Not Available

  • PRCCI Clinical Research Center

    San Juan, 00927
    Puerto Rico

    Site Not Available

  • Pinnacle Research Group

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Cullman Clinical Trials

    Cullman, Alabama 35055
    United States

    Site Not Available

  • Foothills Research Center/ CCT Research

    Phoenix, Arizona 85044
    United States

    Site Not Available

  • Anaheim Clinical Trials

    Anaheim, California 92801
    United States

    Site Not Available

  • ProSciento

    Chula Vista, California 91911
    United States

    Site Not Available

  • Velocity Clinical Research

    La Mesa, California 91941
    United States

    Site Not Available

  • Valiance Clinical Research

    S. Gate, California 90280
    United States

    Site Not Available

  • Northern California Research

    Sacramento, California 95821
    United States

    Site Not Available

  • Acclaim Clinical Research

    San Diego, California 92120
    United States

    Site Not Available

  • America Clinical Trials

    Tarzana, California 91356
    United States

    Site Not Available

  • Valiance Clinical Research

    Tarzana, California 91356
    United States

    Site Not Available

  • Elite Clinical Trials

    Wildomar, California 92595
    United States

    Site Not Available

  • Southwest General Healthcare Center

    Fort Myers, Florida 33907
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • IMA Clinical Research St. Petersburg

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Precision Clinical Research, LLC

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Tampa, Florida 33606
    United States

    Site Not Available

  • Clinical Research of Central Florida

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Center for Advanced Research & Education

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Balanced Life Health Care Solutions/SKYCRNG

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Elite Clinical Trials

    Blackfoot, Idaho 83221
    United States

    Site Not Available

  • PERC dba Central Illinois Diabetes & Clinical Research

    Springfield, Illinois 62701
    United States

    Site Not Available

  • The South Bend Clinic Center for Research

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • IMA Clinical Research Monroe - Armand

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Prime Health and Wellness/SKYCRNG

    Fayette, Mississippi 39069
    United States

    Site Not Available

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi 38654
    United States

    Site Not Available

  • Sky Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • Jefferson City Medical Group

    Jefferson City, Missouri 65109
    United States

    Site Not Available

  • Clinvest Research

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Mercury Street Medical Group, PLLC

    Butte, Montana 59701
    United States

    Site Not Available

  • Cenexel Hassman Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Rochester Clinical Research

    Rochester, New York 14609
    United States

    Site Not Available

  • Accellacare

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Accellacare of Salisbury

    Salisbury, North Carolina 284144
    United States

    Site Not Available

  • Accellacare of Piedmont

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Accellacare of Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Accellacare of Winston Salem

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Javara Inc. / Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Velocity Clinical Research, Inc.

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • AMR Norman

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Tribe Clinical Research, LLC.

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Accellacare of Charleston / Charleston-Roper St. Francis Physician Partners Primary Care

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Accellacare of Bristol / Internal Medicine and Pediatric Associates of Bristol, P.C.

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Chattanooga Medical Research

    Chattanooga, Tennessee 37412
    United States

    Site Not Available

  • Accellacare of Knoxville / Summit-Halls Family Practice

    Knoxville, Tennessee 37938
    United States

    Site Not Available

  • Velocity Clinical Research Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Medresearch Inc

    El Paso, Texas 79902
    United States

    Site Not Available

  • Valley Institute of Research

    Fort Worth, Texas 76164
    United States

    Site Not Available

  • Consano Clinical Research

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia 23606
    United States

    Site Not Available

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