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Trevogrumab-Part A

Phase 2

Obesity | Small molecule | Metabolic |Regeneron Pharmaceuticals, Inc.|Last Updated: Sep 1, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,005

FDA Designations

No designations recorded

Clinical trial landscape

Trevogrumab-Part A · 1 trial · 1 indication

Phase 2 1
NCT06299098A 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 PreservationObesity
ACTIVE NOT_RECRUITING1,005 Analytics
PHASE2ACTIVE NOT_RECRUITING
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
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Concentrations of trevogrumab in serum over time
Up to 75 weeks
Percent change in total fat mass
Baseline to week 52
Percent change in total lean mass
Baseline to week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPart A Randomized 1:1
TrevogrumabEXPERIMENTALPart A Randomized 1:1
Arm A0EXPERIMENTALPart 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 A1EXPERIMENTALPart B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
Arm B0EXPERIMENTALPart B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm B1EXPERIMENTALPart B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm C0EXPERIMENTALPart B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm C1EXPERIMENTALPart B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm D0EXPERIMENTALPart B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Arm D1EXPERIMENTALPart B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Arm 1EXPERIMENTALPart C Sema and SC placebo Randomized 1:2:2
Arm 2EXPERIMENTALPart C Sema and SC low dose trevo Randomized 1:2:2
Arm 3EXPERIMENTALPart C Sema and SC moderate dose trevo Randomized 1:2:2

Interventions

NameTypeDescription
Trevogrumab-Part ADRUGAdministered IV or SC in Part A
Trevogrumab-Part B and Part CDRUGAdministered SC in Part B, Part C
GaretosmabDRUGAdministered IV in Part B
SemaglutideDRUGAdministered SC in Part B and Part C
Matching Placebo-Part ADRUGAdministered IV or SC in Part A
Matching Placebo-TrevogrumabDRUGAdministered SC in Part B and Part C
Matching Placebo-GaretosmabDRUGAdministered IV in Part B
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites60

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 screenin...

Countries:United StatesPuerto Rico
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Recent Changes (Last 90 Days)

LOWSep 1, 2026NCT06299098primaryCompletionDate: changed
LOWSep 1, 2026NCT06299098primaryCompletionDate: changed
LOWJul 21, 2026NCT06299098primaryCompletionDate: changed

Frequently asked questions about Trevogrumab-Part A

What is Trevogrumab-Part A used for?

Trevogrumab-Part A is an investigational small molecule being studied for the treatment of obesity. It is being evaluated in a Phase 2 clinical trial for its effects on weight loss, fat loss, and lean mass preservation in adult patients with obesity.

Who is developing Trevogrumab-Part A?

Trevogrumab-Part A is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting a Phase 2 clinical trial to evaluate the drug's safety and efficacy in patients with obesity.

What phase is Trevogrumab-Part A in?

Trevogrumab-Part A is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants.

What clinical trials is Trevogrumab-Part A in?

Trevogrumab-Part A is being studied in a Phase 2 clinical trial with the identifier NCT06299098. This randomized, double-blind, placebo-controlled trial enrolls approximately 1005 participants and is being conducted in the United States and Puerto Rico.

How is Trevogrumab-Part A being tested in obesity?

In the Phase 2 trial NCT06299098, Trevogrumab-Part A is being tested alone or in combination with garetosmab, both administered with semaglutide, in adult patients with obesity. The study aims to assess safety and efficacy for weight loss, fat loss, and lean mass preservation.