ACTIVE_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

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Conditions

ObesityObesity without diabetesQuality of weight lossFat mass lossLean mass loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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

Quick Facts

Study Start:2024-03-13
Study Completion:2026-11-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06299098

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Pinnacle Research Group
Anniston, Alabama, 36207
United States
Cullman Clinical Trials
Cullman, Alabama, 35055
United States
Foothills Research Center Cct Research
Phoenix, Arizona, 85044
United States
Anaheim Clinical Trials
Anaheim, California, 92801
United States
ProSciento
Chula Vista, California, 91911
United States
Valiance Clinical Research- Huntington Park
Huntington Park, California, 91356
United States
Velocity, San Diego
La Mesa, California, 91941
United States
Northern California Research
Sacramento, California, 95821
United States
Acclaim Clinical Research
San Diego, California, 92120
United States
Metabolic Institute of America
Tarzana, California, 91356
United States
Valiance Clinical Research
Tarzana, California, 91356
United States
Southwest General Healthcare Center
Fort Myers, Florida, 33907
United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
IMA Clinical Research St. Petersburg
Saint Petersburg, Florida, 33709
United States
Precision Clinical Research, LLC
Sunrise, Florida, 33351
United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33606
United States
Clinical Research of Central Florida - Bond Clinic
Winter Haven, Florida, 33880
United States
Center for Advanced Research and Education
Gainesville, Georgia, 30501
United States
Balanced Life Health Care Solutions
Lawrenceville, Georgia, 30046
United States
North Georgia Clinical Research
Woodstock, Georgia, 30189
United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814
United States
Elite Clinical Trials LLLP
Blackfoot, Idaho, 83221
United States
Prairie Education and Research Cooperative (PERC)
Springfield, Illinois, 62701
United States
The South Bend Clinic Center for Research
South Bend, Indiana, 46617
United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
United States
L-MARC Research Center
Louisville, Kentucky, 40213
United States
Tandem Clinical Research GI, LLC
Marrero, Louisiana, 70072
United States
IMA Clinical Research Monroe - Armand
Monroe, Louisiana, 71201
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Prime Health and Wellness Clinic
Fayette, Mississippi, 39069
United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
United States
Sky Integrative Medical Center Skycrng
Ridgeland, Mississippi, 39157
United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109
United States
Clinvest Research
Springfield, Missouri, 65807
United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
United States
Hassman Research Institute
Berlin, New Jersey, 08009
United States
Accellacare Clinical Research, Raleigh Medical Group
Raleigh, North Carolina, 27609
United States
Accellacare of Salisbury
Salisbury, North Carolina, 28144
United States
Accellacare of Piedmont, Piedmont Healthcare
Statesville, North Carolina, 28625
United States
Pmg Research of Wilmington Llc
Wilmington, North Carolina, 28401
United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
United States
Javara Incorporated at Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Velocity Clinical Research Inc.
Cincinnati, Ohio, 45219
United States
AMR Norman
Norman, Oklahoma, 73069
United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
United States
Tribe Clinical Research Llc
Greenville, South Carolina, 29607
United States
PMG Research of Charleston
Mount Pleasant, South Carolina, 29464
United States
Pmg Research of Bristol
Bristol, Tennessee, 37620
United States
Chattanooga Medical Research
Chattanooga, Tennessee, 37412
United States
PMG Research of Knoxville - Merchant Drive
Knoxville, Tennessee, 37912
United States
PMG Research of Knoxville - Emory Road
Knoxville, Tennessee, 37938
United States
Velocity Clinical Research Dallas
Dallas, Texas, 75230
United States
Medresearch Inc
El Paso, Texas, 79902
United States
Valley Institute of Research
Fort Worth, Texas, 76164
United States
Consano Clinical Research
Shavano Park, Texas, 78231
United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911
United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-13
Study Completion Date2026-11-04

Study Record Updates

Study Start Date2024-03-13
Study Completion Date2026-11-04

Terms related to this study

Keywords Provided by Researchers

  • Obesity without diabetes
  • Quality of weight loss
  • Fat mass loss
  • Lean mass loss

Additional Relevant MeSH Terms

  • Obesity