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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

Phase 2
Active, not recruiting
Conditions
Obesity
Interventions
Drug: Matching Placebo-Part A
Drug: Trevogrumab-Part A
Drug: Trevogrumab-Part B and Part C
Drug: Matching Placebo-Trevogrumab
Drug: Matching Placebo-Garetosmab
Registration Number
NCT06299098
Lead Sponsor
Regeneron Pharmaceuticals
Brief 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)

Detailed Description

Part A Healthy Volunteers

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

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1005
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
PlaceboMatching Placebo-Part APart A Randomized 1:1
TrevogrumabTrevogrumab-Part APart A Randomized 1:1
Arm A0SemaglutidePart B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm A0Matching Placebo-TrevogrumabPart B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm A0Matching Placebo-GaretosmabPart B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm A1Trevogrumab-Part B and Part CPart B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
Arm A1SemaglutidePart B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
Arm A1Matching Placebo-TrevogrumabPart B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
Arm A1Matching Placebo-GaretosmabPart B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
Arm B0Trevogrumab-Part B and Part CPart B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm B0SemaglutidePart B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm B0Matching Placebo-TrevogrumabPart B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm B0Matching Placebo-GaretosmabPart B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm B1Trevogrumab-Part B and Part CPart B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm B1SemaglutidePart B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm B1Matching Placebo-GaretosmabPart B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm C0Trevogrumab-Part B and Part CPart B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm C0SemaglutidePart B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm C0Matching Placebo-TrevogrumabPart B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm C0Matching Placebo-GaretosmabPart B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm C1Trevogrumab-Part B and Part CPart B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm C1SemaglutidePart B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm C1Matching Placebo-GaretosmabPart B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm D0Trevogrumab-Part B and Part CPart B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm D0GaretosmabPart B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm D0SemaglutidePart B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm D0Matching Placebo-TrevogrumabPart B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm D1Trevogrumab-Part B and Part CPart B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm D1GaretosmabPart B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm D1SemaglutidePart B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm 1SemaglutidePart C Sema and SC placebo Randomized 1:2:2
Arm 1Matching Placebo-TrevogrumabPart C Sema and SC placebo Randomized 1:2:2
Arm 2Trevogrumab-Part B and Part CPart C Sema and SC low dose trevo Randomized 1:2:2
Arm 2SemaglutidePart C Sema and SC low dose trevo Randomized 1:2:2
Arm 2Matching Placebo-TrevogrumabPart C Sema and SC low dose trevo Randomized 1:2:2
Arm 3Trevogrumab-Part B and Part CPart C Sema and SC moderate dose trevo Randomized 1:2:2
Arm 3SemaglutidePart C Sema and SC moderate dose trevo Randomized 1:2:2
Primary Outcome Measures
NameTimeMethod
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 52

Part C

Percent change in total lean massBaseline to week 52

Part C

Percent change in body weightBaseline to week 52

Part C

Secondary Outcome Measures
NameTimeMethod
Concentrations of trevogrumab in serum over timeUp to 75 weeks

Part A, Part B, and Part C

Percent change in total fat massBaseline to week 26

Part C

Percent change in total lean massBaseline to week 26

Part C

Percent change in body weightBaseline to week 26

Part C

Change in waist circumference (cm)Baseline to week 52

Part C

Percent change in fasting serum triglyceridesBaseline to week 26

Part B

Percent change in total cholesterolBaseline to week 26

Part B

Percent change in Apolipoprotein B (Apo B)Baseline to week 26

Part B

Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)Baseline to week 26

Part B

Concentrations of garetosmab in serum over timeUp to 75 weeks

Part B

Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over timeUp to 75 weeks

Part B and Part C

Titer of ADAs to trevogrumab after repeated doses over timeUp to 75 weeks

Part B and Part C

Incidence of ADAs to garetosmab after repeated doses over timeUp to 75 weeks

Part B

Titer of ADAs to garetosmab after repeated doses over timeUp to 75 weeks

Part B

Incidence of TEAEsUp to 75 weeks

Part B and Part C

Severity of TEAEsUp to 75 weeks

Part B and Part C

Concentration of total Growth Differentiation Factor (GDF) 8 in serum over timeUp to 75 weeks

Part C

Related Research Topics

Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.

What molecular mechanisms underlie trevogrumab and garetosmab's synergistic effects with semaglutide in obesity treatment?
How does the combination of trevogrumab/Garetosmab and semaglutide compare to standard-of-care GLP-1 agonists in weight loss efficacy?
Which pharmacodynamic biomarkers predict response to trevogrumab and garetosmab in semaglutide-treated obesity patients?
What are the most common adverse events reported in NCT06299098's semaglutide-combination therapy arms for obesity?
Are there other Regeneron investigational agents targeting the same metabolic pathways as trevogrumab for obesity management?

Trial Locations

Locations (60)

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

Scroll for more (50 remaining)
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States

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