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HomeTrials › NCT05567796

Obesity & weight · Phase 3 · Active, not recruiting

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

NCT05567796 · Sponsor: Novo Nordisk A/S

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide for obesity.

Who can joinAll sexes, No stated age limits
Healthy volunteersNo — diagnosis required
What you'd takeCagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide
Study length~2 years overall
Planned participants3,400
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: * Male or female * Age above or equal to 18 years at the time of signing informed consent * Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m\^2) or b) BMI greater than or equal to 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease Exclusion Criteria: \- Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus

Study sites by state

Alabama

  • Univ of Alabama Birmingham — Birmingham

California

  • Velocity Clin Res Los Angeles — Los Angeles
  • Velocity Clin Res Wstlke — Los Angeles

Colorado

  • Univ of Colorado at Denver — Aurora
  • OptumCare Clinical Trials LLC — Golden

Florida

  • Northeast Research Institute — Fleming Island
  • South Broward Research LLC — Miramar
  • Clinical Neuroscience Solution — Orlando
  • Florida Inst For Clin Res — Orlando
  • Clinical Trial Res Assoc,Inc — Plantation

Georgia

  • Hope Clin Res & Wellness — Conyers

Hawaii

  • East West Med Res Inst — Honolulu

Illinois

  • Great Lakes Clinical Trials — Chicago
  • Endeavor Health — Skokie
  • Evanston Premier Hlthcr Res — Skokie

Indiana

  • Midwest Inst For Clin Res — Indianapolis

Michigan

  • Northern Pines Hlth Ctr, PC — Buckley

Missouri

  • StudyMetrix Research LLC — City of Saint Peters

New York

  • Velocity Clinical Research Binghamton — Binghamton
  • Comprehensive Weight Ctrl Prog — New York

North Carolina

  • University of North Carolina — Chapel Hill
  • University of North Carolina — Chapel Hill
  • Medication Mgmnt, LLC_Grnsboro — Greensboro
  • PharmQuest Life Sciences LLC — Greensboro
  • Accellacare_NC — Raleigh
  • Accellacare — Wilmington

Ohio

  • New Venture Medical Research — Wadsworth

Oklahoma

  • Lynn Institute of Norman — Norman

Pennsylvania

  • The University of Penn Center — Philadelphia

Rhode Island

  • Clinical Res Collaborative — Cumberland

South Carolina

  • Medical Uni of SC Charleston — Charleston
  • Coastal Carolina Res Ctr — North Charleston
  • Hillcrest Clinical Research — Simpsonville
  • Spartanburg Medical Research — Spartanburg

Tennessee

  • Holston Medical Group_Bristol — Bristol
  • Holston Medical Group — Kingsport

Texas

  • Baylr Sctt White Rs Inst, Endo — Dallas
  • Velocity Clinical Res-Dallas — Dallas
  • UT Southwestern Med Cntr — Dallas
  • DCOL Ctr for Clin Res — Longview

Virginia

  • Washington Cntr Weight Mgmt — Arlington
  • Health Res of Hampton Roads — Newport News
  • Selma Medical Associates — Winchester

Washington

  • Capital Clin Res Ctr,LLC — Olympia
  • Rainier Clin Res Ctr Inc — Renton

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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