Clinical trial NCT06299098: 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 and Fat Loss
Official title: A Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity without diabetes
Quality of weight loss
Fat mass loss
Lean mass loss
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline to week 7
measure: Severity of TEAEs
timeFrame: Baseline to week 7
measure: Percent body weight change
timeFrame: Baseline to week 26
measure: Percent change in total fat mass
timeFrame: Baseline to week 26
Secondary outcomes:
measure: Concentrations of trevogrumab in serum over time
timeFrame: Up to 75 weeks
measure: Concentration of total Growth Differentiation Factor (GDF)8 in serum over time
timeFrame: Up to 75 weeks
measure: Percent body weight change
timeFrame: Baseline to week 52
measure: Percent change in total fat mass
timeFrame: Baseline to week 52
measure: Percent change in total lean mass
timeFrame: Baseline to week 26
measure: Change in waist circumference (cm)
timeFrame: Baseline to week 26
measure: Percent change in body weight
timeFrame: Baseline to week 52
measure: Percent change in total lean mass
timeFrame: Baseline to week 52
measure: Percent change in regional measurements of body composition
timeFrame: Baseline to week 26
measure: Percent change in gynoid fat mass
timeFrame: Baseline to week 26
measure: Change in total lean mass:total fat mass ratio
timeFrame: Baseline to week 26
measure: Proportion of weight loss attributable to fat mass loss
timeFrame: Baseline to week 26
measure: Percent change in android (central) fat mass
timeFrame: Baseline to week 26
measure: Body weight reduction of ≥5%
timeFrame: Baseline to week 26
measure: Body weight reduction of ≥10%
timeFrame: Baseline to week 26
measure: Body weight reduction of ≥15%
timeFrame: Baseline to week 26
measure: Body weight reduction of ≥20%
timeFrame: Baseline to week 26
measure: Body weight reduction of ≥25%
timeFrame: Baseline to week 26
measure: Percent change in fasting serum triglycerides
timeFrame: Baseline to week 26
measure: Percent change in total cholesterol
timeFrame: Baseline to week 26
measure: Percent change in Apolipoprotein B (Apo B)
timeFrame: Baseline to week 26
measure: Percent change in low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline to week 26
measure: Change in physical function domain (5 items) score of Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQoLLite- CT)
timeFrame: Baseline to week 26
measure: Change in physical functioning domain score of SF-36
timeFrame: Baseline to week 26
measure: Concentrations of garetosmab in serum over time
timeFrame: Up to 75 weeks
measure: Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time
timeFrame: Up to 75 weeks
measure: Titer of ADAs to trevogrumab after repeated doses over time
timeFrame: Up to 75 weeks
measure: Incidence of ADAs to garetosmab after repeated doses over time
timeFrame: Up to 75 weeks
measure: Titer of ADAs to garetosmab after repeated doses over time
timeFrame: Up to 75 weeks
measure: Incidence of TEAEs
timeFrame: Up to 75 weeks
measure: Severity of TEAEs
timeFrame: Up to 75 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Phoenix
country: United States
facility: Foothills Research Center Cct Research
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Chula Vista
country: United States
facility: ProSciento
state: California
city: Huntington Park
country: United States
facility: Valiance Clinical Research- Huntington Park
state: California
city: La Mesa
country: United States
facility: Velocity, San Diego
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: Tarzana
country: United States
facility: Metabolic Institute of America
state: California
city: Tarzana
country: United States
facility: Valiance Clinical Research
state: California
city: Fort Myers
country: United States
facility: Southwest General Healthcare Center
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Saint Petersburg
country: United States
facility: IMA Clinical Research St. Petersburg
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida - Bond Clinic
state: Florida
city: Gainesville
country: United States
facility: Center for Advanced Research and Education
state: Georgia
city: Lawrenceville
country: United States
facility: Balanced Life Health Care Solutions
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Blackfoot
country: United States
facility: Elite Clinical Trials LLLP
state: Idaho
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative (PERC)
state: Illinois
city: South Bend
country: United States
facility: The South Bend Clinic Center for Research
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research GI, LLC
state: Louisiana
city: Monroe
country: United States
facility: IMA Clinical Research Monroe - Armand
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Fayette
country: United States
facility: Prime Health and Wellness Clinic
state: Mississippi
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Ridgeland
country: United States
facility: Sky Integrative Medical Center Skycrng
state: Mississippi
city: Jefferson City
country: United States
facility: Jefferson City Medical Group
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Raleigh
country: United States
facility: Accellacare Clinical Research, Raleigh Medical Group
state: North Carolina
city: Salisbury
country: United States
facility: Accellacare of Salisbury
state: North Carolina
city: Statesville
country: United States
facility: Accellacare of Piedmont, Piedmont Healthcare
state: North Carolina
city: Wilmington
country: United States
facility: Pmg Research of Wilmington Llc
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Javara Incorporated at Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Velocity Clinical Research Inc.
state: Ohio
city: Norman
country: United States
facility: AMR Norman
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research Llc
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston
state: South Carolina
city: Bristol
country: United States
facility: Pmg Research of Bristol
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga Medical Research
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville - Merchant Drive
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville - Emory Road
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Research Dallas
state: Texas
city: El Paso
country: United States
facility: Medresearch Inc
state: Texas
city: Fort Worth
country: United States
facility: Valley Institute of Research
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion (FDI) Clinical Research
city: San Juan
country: Puerto Rico
facility: PRCCI Clinical Research Center
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: