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
- Conditions
- Obesity
- Interventions
- Drug: Trevogrumab-Part B and Part CDrug: Matching Placebo-Part ADrug: Trevogrumab-Part ADrug: Matching Placebo-GaretosmabDrug: Matching Placebo-Trevogrumab
- 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
- RECRUITING
- Sex
- All
- Target Recruitment
- 999
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm C1 Trevogrumab-Part B and Part C Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 Arm C1 Semaglutide Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 Arm C1 Matching Placebo-Garetosmab Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 Arm D0 Trevogrumab-Part B and Part C Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Arm D0 Garetosmab Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Arm D0 Semaglutide Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Arm D0 Matching Placebo-Trevogrumab Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Arm D1 Trevogrumab-Part B and Part C Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 Arm D1 Garetosmab Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 Arm D1 Semaglutide Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 Arm 1 Semaglutide Part C Sema and SC placebo Randomized 1:2:2 Arm 1 Matching Placebo-Trevogrumab Part C Sema and SC placebo Randomized 1:2:2 Arm 2 Trevogrumab-Part B and Part C Part C Sema and SC low dose trevo Randomized 1:2:2 Arm 2 Semaglutide Part C Sema and SC low dose trevo Randomized 1:2:2 Arm 2 Matching Placebo-Trevogrumab Part C Sema and SC low dose trevo Randomized 1:2:2 Arm 3 Trevogrumab-Part B and Part C Part C Sema and SC moderate dose trevo Randomized 1:2:2 Arm 3 Semaglutide Part C Sema and SC moderate dose trevo Randomized 1:2:2 Arm 3 Matching Placebo-Trevogrumab Part C Sema and SC moderate dose trevo Randomized 1:2:2 Arm C0 Matching Placebo-Garetosmab Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Placebo Matching Placebo-Part A Part A Randomized 1:1 Trevogrumab Trevogrumab-Part A Part A Randomized 1:1 Arm A0 Semaglutide 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 Arm A0 Matching Placebo-Trevogrumab 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 Arm A0 Matching Placebo-Garetosmab 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 Arm A1 Trevogrumab-Part B and Part C Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1 Arm A1 Semaglutide Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1 Arm A1 Matching Placebo-Trevogrumab Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1 Arm A1 Matching Placebo-Garetosmab Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1 Arm B0 Trevogrumab-Part B and Part C Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Arm B0 Semaglutide Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Arm B0 Matching Placebo-Trevogrumab Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Arm B0 Matching Placebo-Garetosmab Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Arm B1 Trevogrumab-Part B and Part C Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 Arm B1 Semaglutide Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 Arm B1 Matching Placebo-Garetosmab Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 Arm C0 Trevogrumab-Part B and Part C Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Arm C0 Semaglutide Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 Arm C0 Matching Placebo-Trevogrumab Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) Baseline to week 7 Part A
Severity of TEAEs Baseline to week 7 Part A
Percent body weight change Baseline to week 26 Part B and Part C
Percent change in total fat mass Baseline to week 26 Part B and Part C
- Secondary Outcome Measures
Name Time Method Concentrations of trevogrumab in serum over time Up to 75 weeks Part A, Part B, and Part C
Concentration of total Growth Differentiation Factor (GDF)8 in serum over time Up to 75 weeks Part C
Percent body weight change Baseline to week 52 Part B
Percent change in total fat mass Baseline to week 52 Part B
Percent change in total lean mass Baseline to week 52 Part B
Change in waist circumference (cm) Baseline to week 26 Part B
Percent change in body weight Baseline to week 52 Part B
Percent change in regional measurements of body composition Baseline to week 26 Part B
Percent change in gynoid fat mass Baseline to week 26 Part B
Change in total lean mass:total fat mass ratio Baseline to week 26 Part B
Proportion of weight loss attributable to fat mass loss Baseline to week 26 Part B
Percent change in android (central) fat mass Baseline to week 26 Part B
Body weight reduction of ≥5% Baseline to week 26 Part B
Body weight reduction of ≥10% Baseline to week 26 Part B
Body weight reduction of ≥15% Baseline to week 26 Part B
Body weight reduction of ≥20% Baseline to week 26 Part B
Body weight reduction of ≥25% Baseline to week 26 Part B
Percent change in fasting serum triglycerides Baseline to week 26 Part B
Percent change in total cholesterol Baseline 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
Change in physical function domain (5 items) score of Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQoLLite- CT) Baseline to week 26 Part B IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assesses the 'physical function score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.
Change in physical functioning domain score of SF-36 Baseline to week 26 Part B Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
Concentrations of garetosmab in serum over time Up to 75 weeks Part B
Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time Up to 75 weeks Part B and Part C
Titer of ADAs to trevogrumab after repeated doses over time Up to 75 weeks Part B and Part C
Incidence of ADAs to garetosmab after repeated doses over time Up to 75 weeks Part B
Titer of ADAs to garetosmab after repeated doses over time Up to 75 weeks Part B
Incidence of TEAEs Up to 75 weeks Part B and Part C
Severity of TEAEs Up to 75 weeks Part B and Part C
Trial Locations
- Locations (61)
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
Valiance Clinical Research
🇺🇸Tarzana, California, United States
Southwest General Healthcare Center
🇺🇸Fort Myers, Florida, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
IMA Clinical Research St. Petersburg
🇺🇸Saint Petersburg, Florida, United States
Precision Clinical Research, LLC
🇺🇸Sunrise, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Clinical Research of Central Florida - Bond Clinic
🇺🇸Winter Haven, Florida, United States
Center for Advanced Research and Education
🇺🇸Gainesville, Georgia, United States
Balanced Life Health Care Solutions
🇺🇸Lawrenceville, Georgia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Elite Clinical Trials LLLP
🇺🇸Blackfoot, Idaho, United States
Prairie Education and Research Cooperative (PERC)
🇺🇸Springfield, Illinois, United States
The South Bend Clinic Center for Research
🇺🇸South Bend, Indiana, United States
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Tandem Clinical Research GI, LLC
🇺🇸Marrero, Louisiana, United States
IMA Clinical Research Monroe - Armand
🇺🇸Monroe, Louisiana, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Prime Health and Wellness Clinic
🇺🇸Fayette, Mississippi, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
Sky Integrative Medical Center Skycrng
🇺🇸Ridgeland, Mississippi, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Clinvest Research
🇺🇸Springfield, Missouri, United States
Mercury Street Medical Group, PLLC
🇺🇸Butte, Montana, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
Accellacare Clinical Research, Raleigh Medical Group
🇺🇸Raleigh, North Carolina, United States
Accellacare of Salisbury
🇺🇸Salisbury, North Carolina, United States
Accellacare of Piedmont, Piedmont Healthcare
🇺🇸Statesville, North Carolina, United States
Pmg Research of Wilmington Llc
🇺🇸Wilmington, North Carolina, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
Javara Incorporated at Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Velocity Clinical Research Inc.
🇺🇸Cincinnati, Ohio, United States
AMR Norman
🇺🇸Norman, Oklahoma, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Tribe Clinical Research Llc
🇺🇸Greenville, South Carolina, United States
PMG Research of Charleston
🇺🇸Mount Pleasant, South Carolina, United States
Pmg Research of Bristol
🇺🇸Bristol, Tennessee, United States
Chattanooga Medical Research
🇺🇸Chattanooga, Tennessee, United States
PMG Research of Knoxville - Merchant Drive
🇺🇸Knoxville, Tennessee, United States
PMG Research of Knoxville - Emory Road
🇺🇸Knoxville, Tennessee, United States
Velocity Clinical Research Dallas
🇺🇸Dallas, Texas, United States
Medresearch Inc
🇺🇸El Paso, Texas, United States
Valley Institute of Research
🇺🇸Fort Worth, Texas, United States
Consano Clinical Research
🇺🇸Shavano Park, Texas, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Fundacion de Investigacion (FDI) Clinical Research
🇵🇷San Juan, Puerto Rico
PRCCI Clinical Research Center
🇵🇷San Juan, Puerto Rico