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
NCT ID: NCT06299098
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
1005 participants
INTERVENTIONAL
2024-03-13
2026-10-30
Brief Summary
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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
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Part B and Part C (starts after treatment for Part A has completed) Participants with Obesity
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Part A Randomized 1:1
Matching Placebo-Part A
Administered IV or SC in Part A
Trevogrumab
Part A Randomized 1:1
Trevogrumab-Part A
Administered IV or SC in Part A
Arm A0
Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Semaglutide
Administered SC in Part B and Part C
Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Matching Placebo-Garetosmab
Administered IV in Part B
Arm A1
Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Semaglutide
Administered SC in Part B and Part C
Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Matching Placebo-Garetosmab
Administered IV in Part B
Arm B0
Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Semaglutide
Administered SC in Part B and Part C
Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Matching Placebo-Garetosmab
Administered IV in Part B
Arm B1
Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Semaglutide
Administered SC in Part B and Part C
Matching Placebo-Garetosmab
Administered IV in Part B
Arm C0
Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Semaglutide
Administered SC in Part B and Part C
Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Matching Placebo-Garetosmab
Administered IV in Part B
Arm C1
Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Semaglutide
Administered SC in Part B and Part C
Matching Placebo-Garetosmab
Administered IV in Part B
Arm D0
Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Garetosmab
Administered IV in Part B
Semaglutide
Administered SC in Part B and Part C
Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Arm D1
Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Garetosmab
Administered IV in Part B
Semaglutide
Administered SC in Part B and Part C
Arm 1
Part C Sema and SC placebo Randomized 1:2:2
Semaglutide
Administered SC in Part B and Part C
Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Arm 2
Part C Sema and SC low dose trevo Randomized 1:2:2
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Semaglutide
Administered SC in Part B and Part C
Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Arm 3
Part C Sema and SC moderate dose trevo Randomized 1:2:2
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Semaglutide
Administered SC in Part B and Part C
Interventions
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Trevogrumab-Part A
Administered IV or SC in Part A
Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Garetosmab
Administered IV in Part B
Semaglutide
Administered SC in Part B and Part C
Matching Placebo-Part A
Administered IV or SC in Part A
Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Matching Placebo-Garetosmab
Administered IV in Part B
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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)
18 Years
80 Years
ALL
Yes
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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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
Countries
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Related Links
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Courage Study
Other Identifiers
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R1033-OB-2288
Identifier Type: -
Identifier Source: org_study_id