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New combo shot aims for major weight loss in obesity trial

NCT ID NCT07011667

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This Phase 3 study tests CagriSema, a weekly injection combining two drugs (cagrilintide and semaglutide), for weight loss and long-term weight maintenance in 609 adults with obesity. Participants are randomly assigned to receive either CagriSema or a placebo for over 3 years. The goal is to see if this combination helps people lose and keep off significant weight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CagriSema (cagrilintide and semaglutide combination)
What this could lead to
If successful, this could offer a powerful new option for significant and sustained weight loss in people with obesity.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The drug may cause side effects, and weight loss may vary. Long-term safety and effectiveness are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

609 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

key Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * BMI ≥ 30.0 kilogram per square meter (kg/m\^2) at screening. * Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation. key Exclusion Criteria: * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • Accellacare

    Wilmington, North Carolina, 28401, United States

  • Accellacare_NC

    Raleigh, North Carolina, 27609, United States

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124, United States

  • Amicis Centers of Clinical Research

    St Louis, Missouri, 63128, United States

  • Center for Diab,Obes & Metab

    Pembroke Pines, Florida, 33024, United States

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864, United States

  • Clinical Research Associates

    Nashville, Tennessee, 37203, United States

  • Coastal Carolina Res Ctr

    North Charleston, South Carolina, 29405, United States

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • Endeavor Health

    Skokie, Illinois, 60077, United States

  • Endocrine Research Solutions

    Roswell, Georgia, 30076, United States

  • Evanston Premier Hlthcr Res

    Skokie, Illinois, 60077, United States

  • FDRC

    Costa Mesa, California, 92627, United States

  • Florida Inst For Clin Res LLC

    Orlando, Florida, 32825, United States

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640, United States

  • Great Lakes Medical Research

    Westfield, New York, 14787, United States

  • Health Res of Hampton Roads

    Newport News, Virginia, 23606, United States

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681-1538, United States

  • Holston Medical Group

    Kingsport, Tennessee, 37660, United States

  • Hope Clin Res & Wellness

    Conyers, Georgia, 30094, United States

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50266, United States

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida, 32216, United States

  • Linda Vista Health Care Ctr

    San Diego, California, 92111, United States

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072, United States

  • Medication Mgmnt, LLC_Grnsboro

    Greensboro, North Carolina, 27405, United States

  • Mercury Str Med Grp, PLLC

    Butte, Montana, 59701, United States

  • Midwest Inst For Clin Res

    Indianapolis, Indiana, 46260, United States

  • New Venture Medical Research

    Wadsworth, Ohio, 44281-9236, United States

  • Northeast Clinical Research of San Antonio

    Schertz, Texas, 78154, United States

  • Northeast Research Institute

    Fleming Island, Florida, 32003, United States

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620, United States

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765, United States

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408, United States

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625, United States

  • PlanIt Research, PLLC

    Houston, Texas, 77079, United States

  • Radiance Clinical Research

    Lampasas, Texas, 76550, United States

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057, United States

  • Selma Medical Associates

    Winchester, Virginia, 22601-3834, United States

  • South Broward Research LLC

    Miramar, Florida, 33027, United States

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224, United States

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303, United States

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27514, United States

  • Velocity Clin Res, Dallas

    Dallas, Texas, 75230, United States

  • Washington Cntr Weight Mgmt

    Arlington, Virginia, 22206, United States

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