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Clinical Trials in the USA / NCT06299098
Active, not recruiting Phase 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

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 CGaretosmab →Semaglutide →Matching 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)

FacilityCityRegionStatus
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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Other trials for the same condition

A Study to Evaluate the Effects of a Dietary Supplement on Weight Management and Appetite Control Active, not recruiting
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes Active, not recruiting
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION) Recruiting
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight Starting soon
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity Active, not recruiting
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