Current partner codePEPTIDESDE
NCT06299098·Phase 2·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 2

Enrollment

1,005

Locations

60

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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)

Full detailed description

Part A Healthy Volunteers Part B and Part C (starts after treatment for Part A has completed) Participants with Obesity

Interventions

Treatment arms and agents.

DRUG

Trevogrumab-Part A

Administered IV or SC in Part A

DRUG

Trevogrumab-Part B and Part C

Administered SC in Part B, Part C

DRUG

Garetosmab

Administered IV in Part B

DRUG

Semaglutide

Administered SC in Part B and Part C

DRUG

Matching Placebo-Part A

Administered IV or SC in Part A

DRUG

Matching Placebo-Trevogrumab

Administered SC in Part B and Part C

DRUG

Matching Placebo-Garetosmab

Administered IV in Part B

Timeline

From registration to results.

  1. First posted

    Mar 7, 2024

  2. Study start

    Mar 13, 2024

  3. Primary completion

    May 6, 2026

  4. Study completion

    Oct 30, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 21, 2026

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
Yes

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

60 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.