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Clinical Trials/NCT06299098
NCT06299098Active, not recruitingPhase 2

A Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity

Regeneron Pharmaceuticals120 sites in 1 country1,005 target enrollmentStarted: March 13, 2024Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Enrollment
1,005
Locations
120
Primary Endpoint
Percent change in total fat mass
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Male or female participants age ≥18 to ≤55 years of age at the time of screening
  • •BMI ≥18 and ≤32 kg/m2, at the screening visit
  • •Part B and Part C
  • •Male or female participants ≥18 to ≤80 years of age at the time of screening
  • •BMI ≥30 kg/m2, at the screening visit
  • •History of 1 or more self-reported unsuccessful dietary attempts to lose weight

Exclusion Criteria

  • •History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted
  • •Previous bariatric surgery or planned bariatric surgery
  • •History of hypertrophic cardiomyopathy
  • •Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy
  • •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)
  • •History of poorly controlled hypertension, as defined in the protocol
  • •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
  • •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
  • •Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc)
  • •Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Arms & Interventions

Arm 1

Experimental

Part C Sema and SC placebo Randomized 1:2:2

Intervention: Matching Placebo-Trevogrumab (Drug)

Arm B0

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Semaglutide (Drug)

Placebo

Placebo Comparator

Part A Randomized 1:1

Intervention: Matching Placebo-Part A (Drug)

Arm A1

Experimental

Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1

Intervention: Trevogrumab-Part B and Part C (Drug)

Arm A1

Experimental

Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Trevogrumab (Drug)

Arm A1

Experimental

Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Garetosmab (Drug)

Arm B0

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Trevogrumab-Part B and Part C (Drug)

Trevogrumab

Experimental

Part A Randomized 1:1

Intervention: Trevogrumab-Part A (Drug)

Arm A0

Experimental

Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Trevogrumab (Drug)

Arm A0

Experimental

Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Garetosmab (Drug)

Arm 2

Experimental

Part C Sema and SC low dose trevo Randomized 1:2:2

Intervention: Matching Placebo-Trevogrumab (Drug)

Arm 2

Experimental

Part C Sema and SC low dose trevo Randomized 1:2:2

Intervention: Trevogrumab-Part B and Part C (Drug)

Arm D0

Experimental

Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Trevogrumab (Drug)

Arm D1

Experimental

Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Intervention: Trevogrumab-Part B and Part C (Drug)

Arm 3

Experimental

Part C Sema and SC moderate dose trevo Randomized 1:2:2

Intervention: Trevogrumab-Part B and Part C (Drug)

Arm 3

Experimental

Part C Sema and SC moderate dose trevo Randomized 1:2:2

Intervention: Semaglutide (Drug)

Arm 2

Experimental

Part C Sema and SC low dose trevo Randomized 1:2:2

Intervention: Semaglutide (Drug)

Arm D1

Experimental

Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Intervention: Semaglutide (Drug)

Arm B0

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Trevogrumab (Drug)

Arm D0

Experimental

Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Garetosmab (Drug)

Arm D0

Experimental

Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Semaglutide (Drug)

Arm B0

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Garetosmab (Drug)

Arm 1

Experimental

Part C Sema and SC placebo Randomized 1:2:2

Intervention: Semaglutide (Drug)

Arm C0

Experimental

Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Semaglutide (Drug)

Arm A0

Experimental

Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Semaglutide (Drug)

Arm C1

Experimental

Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Garetosmab (Drug)

Arm D0

Experimental

Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Trevogrumab-Part B and Part C (Drug)

Arm D1

Experimental

Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Intervention: Garetosmab (Drug)

Arm C0

Experimental

Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Trevogrumab (Drug)

Arm C0

Experimental

Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Garetosmab (Drug)

Arm C1

Experimental

Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Intervention: Trevogrumab-Part B and Part C (Drug)

Arm C0

Experimental

Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

Intervention: Trevogrumab-Part B and Part C (Drug)

Arm B1

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Intervention: Trevogrumab-Part B and Part C (Drug)

Arm B1

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Intervention: Matching Placebo-Garetosmab (Drug)

Arm C1

Experimental

Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Intervention: Semaglutide (Drug)

Arm B1

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

Intervention: Semaglutide (Drug)

Arm A1

Experimental

Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1

Intervention: Semaglutide (Drug)

Outcomes

Primary Outcomes

Percent change in total fat mass

Time Frame: Baseline to week 26

Part B

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 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

  • Change in waist circumference (cm)(Baseline to week 52)
  • Percent change in fasting serum triglycerides(Baseline to week 26)
  • Percent change in total cholesterol(Baseline to week 26)
  • Percent change in Apolipoprotein B (Apo B)(Baseline to week 26)
  • Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline to week 26)
  • Concentrations of garetosmab in serum over time(Up to 75 weeks)
  • Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time(Up to 75 weeks)
  • Magnitude of ADAs to trevogrumab over time(Up to 75 weeks)
  • Incidence of ADAs to garetosmab after repeated doses over time(Up to 75 weeks)
  • Magnitude of ADAs to garetosmab 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)
  • Change in waist circumference (cm)(Baseline to week 26)
  • Percent change in body weight(Baseline to week 52)
  • Concentrations of trevogrumab in serum over time(Up to 75 weeks)
  • Percent change in total fat mass(Baseline to week 26)
  • Percent change in total lean mass(Baseline to week 26)
  • Percent change in body weight(Baseline to week 26)
  • Concentrations of trevogrumab in serum over time(Up to 75 weeks)
  • Percent change in total fat mass(Baseline to week 26)
  • Percent change in total lean mass(Baseline to week 26)
  • Percent change in body weight(Baseline to week 26)
  • Change in waist circumference (cm)(Baseline to week 52)
  • Percent change in fasting serum triglycerides(Baseline to week 26)
  • Percent change in total cholesterol(Baseline to week 26)
  • Percent change in Apolipoprotein B (Apo B)(Baseline to week 26)
  • Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline to week 26)
  • Concentrations of garetosmab in serum over time(Up to 75 weeks)
  • Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time(Up to 75 weeks)
  • Magnitude of ADAs to trevogrumab over time(Up to 75 weeks)
  • Incidence of ADAs to garetosmab after repeated doses over time(Up to 75 weeks)
  • Magnitude of ADAs to garetosmab over time(Up to 75 weeks)
  • Incidence of TEAEs(Up to 75 weeks)
  • Severity of TEAEs(Up to 75 weeks)
  • Concentration of total Growth Differentiation Factor (GDF) 8 in serum over time(Up to 75 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (120)

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