DRUG
Trevogrumab-Part A
Administered IV or SC in Part A
Status
Active, not recruiting
Phase
Phase 2
Enrollment
1,005
Locations
60
Results
Not posted
Publications
0
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)
Part A Healthy Volunteers Part B and Part C (starts after treatment for Part A has completed) Participants with Obesity
Interventions
DRUG
Administered IV or SC in Part A
DRUG
Administered SC in Part B, Part C
DRUG
Administered IV in Part B
DRUG
Administered SC in Part B and Part C
DRUG
Administered IV or SC in Part A
DRUG
Administered SC in Part B and Part C
DRUG
Administered IV in Part B
Timeline
First posted
Mar 7, 2024
Study start
Mar 13, 2024
Primary completion
May 6, 2026
Study completion
Oct 30, 2026
Results posted
Not reported
Registry updated
Jul 21, 2026
Outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time frame · Baseline to week 7
Part A
Severity of TEAEs
Time frame · Baseline to week 7
Part A
Percent change in total fat mass
Time frame · Baseline to week 26
Part B
Percent change in total lean mass
Time frame · Baseline to week 26
Part B
Percent change in body weight
Time frame · Baseline to week 26
Part B
Percent change in total fat mass
Time frame · Baseline to week 52
Part C
Percent change in total lean mass
Time frame · Baseline to week 52
Part C
Percent change in body weight
Time frame · Baseline to week 52
Part C
Concentrations of trevogrumab in serum over time
Time frame · Up to 75 weeks
Part A, Part B, and Part C
Percent change in total fat mass
Time frame · Baseline to week 52
Part B
Percent change in total lean mass
Time frame · Baseline to week 52
Part B
Percent change in body weight
Time frame · Baseline to week 52
Part B
Change in waist circumference (cm)
Time frame · Baseline to week 26
Part B and Part C
Change in waist circumference (cm)
Time frame · Baseline to week 52
Part C
Percent change in fasting serum triglycerides
Time frame · Baseline to week 26
Part B
Percent change in total cholesterol
Time frame · Baseline to week 26
Part B
Percent change in Apolipoprotein B (Apo B)
Time frame · Baseline to week 26
Part B
Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame · Baseline to week 26
Part B
Eligibility
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
Study locations
Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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