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 2Active Not RecruitingNCT06299098

Regeneron Pharmaceuticals1,005 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,005

Conditions

Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs)

Part A

Time frame: Baseline to week 7

Severity of TEAEs

Part A

Time frame: Baseline to week 7

Percent change in total fat mass

Part B

Time frame: Baseline to week 26

Percent change in total lean mass

Part B

Time frame: Baseline to week 26

Percent change in body weight

Part B

Time frame: Baseline to week 26

Percent change in total fat mass

Part C

Time frame: Baseline to week 52

Percent change in total lean mass

Part C

Time frame: Baseline to week 52

Percent change in body weight

Part C

Time frame: Baseline to week 52

Secondary Outcomes

Concentrations of trevogrumab in serum over time

Part A, Part B, and Part C

Time frame: Up to 75 weeks

Percent change in total fat mass

Part B

Time frame: Baseline to week 52

Percent change in total lean mass

Part B

Time frame: Baseline to week 52

Percent change in body weight

Part B

Time frame: Baseline to week 52

Change in waist circumference (cm)

Part B and Part C

Time frame: Baseline to week 26

Change in waist circumference (cm)

Part C

Time frame: Baseline to week 52

Percent change in fasting serum triglycerides

Part B

Time frame: Baseline to week 26

Percent change in total cholesterol

Part B

Time frame: Baseline to week 26

Percent change in Apolipoprotein B (Apo B)

Part B

Time frame: Baseline to week 26

Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)

Part B

Time frame: Baseline to week 26

Concentrations of garetosmab in serum over time

Part B

Time frame: Up to 75 weeks

Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time

Part B and Part C

Time frame: Up to 75 weeks

Magnitude of ADAs to trevogrumab over time

Part B and Part C

Time frame: Up to 75 weeks

Incidence of ADAs to garetosmab after repeated doses over time

Part B

Time frame: Up to 75 weeks

Magnitude of ADAs to garetosmab over time

Part B

Time frame: Up to 75 weeks

Incidence of TEAEs

Part B and Part C

Time frame: Up to 75 weeks

Severity of TEAEs

Part B and Part C

Time frame: Up to 75 weeks

Percent change in total fat mass

Part C

Time frame: Baseline to week 26

Percent change in total lean mass

Part C

Time frame: Baseline to week 26

Percent change in body weight

Part C

Time frame: Baseline to week 26

Concentration of total Growth Differentiation Factor (GDF) 8 in serum over time

Part C

Time frame: Up to 75 weeks