Clinical trial

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

Active, not recruiting · Phase 2 · 2 countries · Registry ID NCT06299098

Active, not recruitingPhase 2Interventional

What this study is about

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)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years
SexAll
Healthy volunteersAccepted
ConditionObesity

Full registry criteria

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

Treatments and study arms

Trevogrumab-Part A

Drug

Administered IV or SC in Part A

Trevogrumab-Part B and Part C

Drug

Administered SC in Part B, Part C

Garetosmab

Drug

Administered IV in Part B

Semaglutide

Drug

Administered SC in Part B and Part C

Matching Placebo-Part A

Drug

Administered IV or SC in Part A

Matching Placebo-Trevogrumab

Drug

Administered SC in Part B and Part C

Matching Placebo-Garetosmab

Drug

Administered IV in Part B

Primary outcomes

Incidence of treatment-emergent adverse events (TEAEs)Baseline to week 7

Part A

Severity of TEAEsBaseline to week 7

Part A

Percent change in total fat massBaseline to week 26

Part B

Percent change in total lean massBaseline to week 26

Part B

Percent change in body weightBaseline to week 26

Part B

Percent change in total fat massBaseline to week 52

Part C

Percent change in total lean massBaseline to week 52

Part C

Percent change in body weightBaseline to week 52

Part C

Study locations

60 locations were listed when this page was built. The first 40 are shown.

Fundacion de Investigacion (FDI) Clinical Research🇵🇷 San Juan, Puerto Rico
PRCCI Clinical Research Center🇵🇷 San Juan, Puerto Rico
Anaheim Clinical Trials🇺🇸 Anaheim, California, United States
Pinnacle Research Group🇺🇸 Anniston, Alabama, United States
Hassman Research Institute🇺🇸 Berlin, New Jersey, United States
Elite Clinical Trials LLLP🇺🇸 Blackfoot, Idaho, United States
Pmg Research of Bristol🇺🇸 Bristol, Tennessee, United States
Mercury Street Medical Group, PLLC🇺🇸 Butte, Montana, United States
Charlottesville Medical Research🇺🇸 Charlottesville, Virginia, United States
Chattanooga Medical Research🇺🇸 Chattanooga, Tennessee, United States
ProSciento🇺🇸 Chula Vista, California, United States
Velocity Clinical Research Inc.🇺🇸 Cincinnati, Ohio, United States
Cullman Clinical Trials🇺🇸 Cullman, Alabama, United States
Velocity Clinical Research Dallas🇺🇸 Dallas, Texas, United States
Altoona Center for Clinical Research🇺🇸 Duncansville, Pennsylvania, United States
Medresearch Inc🇺🇸 El Paso, Texas, United States
Prime Health and Wellness Clinic🇺🇸 Fayette, Mississippi, United States
Southwest General Healthcare Center🇺🇸 Fort Myers, Florida, United States
Valley Institute of Research🇺🇸 Fort Worth, Texas, United States
Center for Advanced Research and Education🇺🇸 Gainesville, Georgia, United States
Tribe Clinical Research Llc🇺🇸 Greenville, South Carolina, United States
East-West Medical Research Institute🇺🇸 Honolulu, Hawaii, United States
Valiance Clinical Research- Huntington Park🇺🇸 Huntington Park, California, United States
Jacksonville Center for Clinical Research🇺🇸 Jacksonville, Florida, United States
Westside Center for Clinical Research🇺🇸 Jacksonville, Florida, United States
Jefferson City Medical Group🇺🇸 Jefferson City, Missouri, United States
PMG Research of Knoxville - Emory Road🇺🇸 Knoxville, Tennessee, United States
PMG Research of Knoxville - Merchant Drive🇺🇸 Knoxville, Tennessee, United States
Velocity, San Diego🇺🇸 La Mesa, California, United States
Balanced Life Health Care Solutions🇺🇸 Lawrenceville, Georgia, 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
PMG Research of Charleston🇺🇸 Mt. Pleasant, South Carolina, United States
Health Research of Hampton Roads, Inc.🇺🇸 Newport News, Virginia, United States
AMR Norman🇺🇸 Norman, Oklahoma, United States
Olive Branch Family Medical Center🇺🇸 Olive Branch, Mississippi, United States
Foothills Research Center Cct Research🇺🇸 Phoenix, Arizona, United States
Accellacare Clinical Research, Raleigh Medical Group🇺🇸 Raleigh, North Carolina, United States
Sky Integrative Medical Center Skycrng🇺🇸 Ridgeland, Mississippi, United States