NCT06299098Active, not recruitingPhase 2
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
A Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1005 (actual)
- First submitted
- 1 Mar 2024
- Start date
- 13 Mar 2024
- Primary completion date
- 16 Jun 2026
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Obesity
- NCT number
- NCT06299098
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 1005
- From 13 Mar 2024 to the primary completion date, 16 Jun 2026
- 60 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous bariatric surgery or planned bariatric surgery
- 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)
- 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
Other illness
- History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted
- History of hypertrophic cardiomyopathy
- History of poorly controlled hypertension, as defined in the protocol
- 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
- Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc)
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Other
- Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy
Who the study is looking for
- Part A
- Male or female participants age ≥18 to ≤55 years of age at the time of screening
- BMI ≥18 and ≤32 kg/m2, at the screening visit
- Part B and Part C
- Male or female participants ≥18 to ≤80 years of age at the time of screening
- BMI ≥30 kg/m2, at the screening visit
- History of 1 or more self-reported unsuccessful dietary attempts to lose weight
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (60)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacion de Investigacion (FDI) Clinical Research Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| PRCCI Clinical Research Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Anaheim Clinical Trials Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Pinnacle Research Group Coordinator of this site? Confirm its status | Anniston | United States | Unknown status |
| Hassman Research Institute Coordinator of this site? Confirm its status | Berlin | United States | Unknown status |
| Elite Clinical Trials LLLP Coordinator of this site? Confirm its status | Blackfoot | United States | Unknown status |
| Pmg Research of Bristol Coordinator of this site? Confirm its status | Bristol | United States | Unknown status |
| Mercury Street Medical Group, PLLC Coordinator of this site? Confirm its status | Butte | United States | Unknown status |
| Charlottesville Medical Research Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Chattanooga Medical Research Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| ProSciento Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
| Velocity Clinical Research Inc. Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cullman Clinical Trials Coordinator of this site? Confirm its status | Cullman | United States | Unknown status |
| Velocity Clinical Research, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Altoona Center For Clinical Research Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| Medresearch Inc Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Prime Health and Wellness Clinic Coordinator of this site? Confirm its status | Fayette | United States | Unknown status |
| Southwest General Healthcare Center Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Valley Institute of Research Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Center for Advanced Research and Education Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Tribe Clinical Research LLC Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| East-West Medical Research Institute Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Valiance Clinical Research: Huntington Park Coordinator of this site? Confirm its status | Huntington Park | United States | Unknown status |
| Westside Center for Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Jacksonville Center for Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Jefferson City Medical Group Coordinator of this site? Confirm its status | Jefferson City | United States | Unknown status |
| PMG Research of Knoxville - Merchant Drive Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| PMG Research of Knoxville - Emory Road Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Velocity, San Diego Coordinator of this site? Confirm its status | La Mesa | United States | Unknown status |
| Balanced Life Health Care Solutions Coordinator of this site? Confirm its status | Lawrenceville | United States | Unknown status |
| L-MARC Research Center Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Tandem Clinical Research GI, LLC Coordinator of this site? Confirm its status | Marrero | United States | Unknown status |
| IMA Clinical Research Monroe - Armand Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| PMG Research of Charleston Coordinator of this site? Confirm its status | Mt. Pleasant | United States | Unknown status |
| Health Research of Hampton Roads, Inc. Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| AMR Norman Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| Olive Branch Family Medical Center Coordinator of this site? Confirm its status | Olive Branch | United States | Unknown status |
| Foothills Research Center Cct Research Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Accellacare Clinical Research, Raleigh Medical Group Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| SKY Integrative Medical Center/SKYCRNG Coordinator of this site? Confirm its status | Ridgeland | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Northern California Research Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Accellacare of Salisbury Coordinator of this site? Confirm its status | Salisbury | United States | Unknown status |
| Acclaim Clinical Research Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Consano Clinical Research Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| The South Bend Clinic Center for Research Coordinator of this site? Confirm its status | South Bend | United States | Unknown status |
| Clinvest Research Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Prairie Education and Research Cooperative (PERC) Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Accellacare of Piedmont - Piedmont HealthCare Coordinator of this site? Confirm its status | Statesville | United States | Unknown status |
| IMA Clinical Research St. Petersburg Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Precision Clinical Research, LLC Coordinator of this site? Confirm its status | Sunrise | United States | Unknown status |
| Clinical Research of West Florida Inc Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Valiance Clinical Research Coordinator of this site? Confirm its status | Tarzana | United States | Unknown status |
| Metabolic Institute of America Coordinator of this site? Confirm its status | Tarzana | United States | Unknown status |
| Cotton O'Neil Clinical Research Center Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| PMG Research of Wilmington, LLC Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| PMG Research of Winston-Salem, LLC Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Javara Incorporated at Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Clinical Research of Central Florida - Bond Clinic Coordinator of this site? Confirm its status | Winter Haven | United States | Unknown status |
| North Georgia Clinical Research Coordinator of this site? Confirm its status | Woodstock | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.