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NCT06299098Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

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)

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
1005 (actual)
First submitted
1 Mar 2024
Start date
13 Mar 2024
Primary completion date
16 Jun 2026
Lead sponsor
Regeneron Pharmaceuticals
Diseases
Obesity
NCT number
NCT06299098

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 1005
  • From 13 Mar 2024 to the primary completion date, 16 Jun 2026
  • 60 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous bariatric surgery or planned bariatric surgery
  • 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)
  • 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

Other illness

  • History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted
  • History of hypertrophic cardiomyopathy
  • 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
  • Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc)
    • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Other

  • Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy

Who the study is looking for

  • Part A
  • 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

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (60)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundacion de Investigacion (FDI) Clinical Research
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San JuanPuerto RicoUnknown status
PRCCI Clinical Research Center
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San JuanPuerto RicoUnknown status
Anaheim Clinical Trials
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AnaheimUnited StatesUnknown status
Pinnacle Research Group
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AnnistonUnited StatesUnknown status
Hassman Research Institute
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BerlinUnited StatesUnknown status
Elite Clinical Trials LLLP
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BlackfootUnited StatesUnknown status
Pmg Research of Bristol
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BristolUnited StatesUnknown status
Mercury Street Medical Group, PLLC
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ButteUnited StatesUnknown status
Charlottesville Medical Research
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CharlottesvilleUnited StatesUnknown status
Chattanooga Medical Research
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ChattanoogaUnited StatesUnknown status
ProSciento
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Chula VistaUnited StatesUnknown status
Velocity Clinical Research Inc.
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CincinnatiUnited StatesUnknown status
Cullman Clinical Trials
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CullmanUnited StatesUnknown status
Velocity Clinical Research, Dallas
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DallasUnited StatesUnknown status
Altoona Center For Clinical Research
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DuncansvilleUnited StatesUnknown status
Medresearch Inc
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El PasoUnited StatesUnknown status
Prime Health and Wellness Clinic
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FayetteUnited StatesUnknown status
Southwest General Healthcare Center
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Fort MyersUnited StatesUnknown status
Valley Institute of Research
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Fort WorthUnited StatesUnknown status
Center for Advanced Research and Education
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GainesvilleUnited StatesUnknown status
Tribe Clinical Research LLC
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GreenvilleUnited StatesUnknown status
East-West Medical Research Institute
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HonoluluUnited StatesUnknown status
Valiance Clinical Research: Huntington Park
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Huntington ParkUnited StatesUnknown status
Westside Center for Clinical Research
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JacksonvilleUnited StatesUnknown status
Jacksonville Center for Clinical Research
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JacksonvilleUnited StatesUnknown status
Jefferson City Medical Group
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Jefferson CityUnited StatesUnknown status
PMG Research of Knoxville - Merchant Drive
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KnoxvilleUnited StatesUnknown status
PMG Research of Knoxville - Emory Road
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KnoxvilleUnited StatesUnknown status
Velocity, San Diego
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La MesaUnited StatesUnknown status
Balanced Life Health Care Solutions
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LawrencevilleUnited StatesUnknown status
L-MARC Research Center
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LouisvilleUnited StatesUnknown status
Tandem Clinical Research GI, LLC
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MarreroUnited StatesUnknown status
IMA Clinical Research Monroe - Armand
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MonroeUnited StatesUnknown status
PMG Research of Charleston
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Mt. PleasantUnited StatesUnknown status
Health Research of Hampton Roads, Inc.
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Newport NewsUnited StatesUnknown status
AMR Norman
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NormanUnited StatesUnknown status
Olive Branch Family Medical Center
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Olive BranchUnited StatesUnknown status
Foothills Research Center Cct Research
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PhoenixUnited StatesUnknown status
Accellacare Clinical Research, Raleigh Medical Group
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RaleighUnited StatesUnknown status
SKY Integrative Medical Center/SKYCRNG
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RidgelandUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
Northern California Research
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SacramentoUnited StatesUnknown status
Accellacare of Salisbury
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SalisburyUnited StatesUnknown status
Acclaim Clinical Research
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San DiegoUnited StatesUnknown status
Consano Clinical Research
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Shavano ParkUnited StatesUnknown status
The South Bend Clinic Center for Research
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South BendUnited StatesUnknown status
Clinvest Research
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SpringfieldUnited StatesUnknown status
Prairie Education and Research Cooperative (PERC)
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SpringfieldUnited StatesUnknown status
Accellacare of Piedmont - Piedmont HealthCare
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StatesvilleUnited StatesUnknown status
IMA Clinical Research St. Petersburg
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St. PetersburgUnited StatesUnknown status
Precision Clinical Research, LLC
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SunriseUnited StatesUnknown status
Clinical Research of West Florida Inc
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TampaUnited StatesUnknown status
Valiance Clinical Research
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TarzanaUnited StatesUnknown status
Metabolic Institute of America
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TarzanaUnited StatesUnknown status
Cotton O'Neil Clinical Research Center
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TopekaUnited StatesUnknown status
PMG Research of Wilmington, LLC
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WilmingtonUnited StatesUnknown status
PMG Research of Winston-Salem, LLC
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Winston-SalemUnited StatesUnknown status
Javara Incorporated at Wake Forest University Health Sciences
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Winston-SalemUnited StatesUnknown status
Clinical Research of Central Florida - Bond Clinic
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Winter HavenUnited StatesUnknown status
North Georgia Clinical Research
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WoodstockUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.