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 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 2

Started

2024-03-13

Last updated

2026-09-01

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Trevogrumab-Part ATrevogrumab-Part B and Part CGaretosmabSemaglutideMatching Placebo-Part AMatching Placebo-TrevogrumabMatching Placebo-Garetosmab

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

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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Incidence of treatment-emergent adverse events (TEAEs) — Baseline to week 7
Part A
Severity of TEAEs — Baseline to week 7
Part A
Percent change in total fat mass — Baseline to week 26
Part B
Percent change in total lean mass — Baseline to week 26
Part B
Percent change in body weight — Baseline to week 26
Part B
Percent change in total fat mass — Baseline to week 52
Part C
Percent change in total lean mass — Baseline to week 52
Part C
Percent change in body weight — Baseline to week 52
Part C

Trial sites (60)

Facility	City	Region
Pinnacle Research Group	Anniston	Alabama
Cullman Clinical Trials	Cullman	Alabama
Foothills Research Center Cct Research	Phoenix	Arizona
Anaheim Clinical Trials	Anaheim	California
ProSciento	Chula Vista	California
Valiance Clinical Research- Huntington Park	Huntington Park	California
Velocity, San Diego	La Mesa	California
Northern California Research	Sacramento	California
Acclaim Clinical Research	San Diego	California
Metabolic Institute of America	Tarzana	California
Valiance Clinical Research	Tarzana	California
Southwest General Healthcare Center	Fort Myers	Florida
Westside Center for Clinical Research	Jacksonville	Florida
Jacksonville Center for Clinical Research	Jacksonville	Florida
IMA Clinical Research St. Petersburg	St. Petersburg	Florida
Precision Clinical Research, LLC	Sunrise	Florida
Clinical Research of West Florida, Inc.	Tampa	Florida
Clinical Research of Central Florida - Bond Clinic	Winter Haven	Florida
Center for Advanced Research and Education	Gainesville	Georgia
Balanced Life Health Care Solutions	Lawrenceville	Georgia
North Georgia Clinical Research	Woodstock	Georgia
East-West Medical Research Institute	Honolulu	Hawaii
Elite Clinical Trials LLLP	Blackfoot	Idaho
Prairie Education and Research Cooperative (PERC)	Springfield	Illinois
The South Bend Clinic Center for Research	South Bend	Indiana
Cotton O'Neil Clinical Research Center	Topeka	Kansas
L-MARC Research Center	Louisville	Kentucky
Tandem Clinical Research GI, LLC	Marrero	Louisiana
IMA Clinical Research Monroe - Armand	Monroe	Louisiana
Mayo Clinic	Rochester	Minnesota
Prime Health and Wellness Clinic	Fayette	Mississippi
Olive Branch Family Medical Center	Olive Branch	Mississippi
Sky Integrative Medical Center Skycrng	Ridgeland	Mississippi
Jefferson City Medical Group	Jefferson City	Missouri
Clinvest Research	Springfield	Missouri
Mercury Street Medical Group, PLLC	Butte	Montana
Hassman Research Institute	Berlin	New Jersey
Accellacare Clinical Research, Raleigh Medical Group	Raleigh	North Carolina
Accellacare of Salisbury	Salisbury	North Carolina
Accellacare of Piedmont, Piedmont Healthcare	Statesville	North Carolina

+ 20 more sites — see the full list on the official registry below.

On this site

📄 Ozempic (semaglutide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06299098 on ClinicalTrials.gov ↗ ← All trials in the USA