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ObesityPhase 3NCT06131437

A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

A Phase 3 study testing Cagrilintide, Semaglutide and Tirzepatide in people with Obesity, run by Novo Nordisk A/S at 46 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Cagrilintide, Semaglutide and Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
809 participants
Where
46 sitesUnited States
Study dates
27 Nov 2023to 9 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female
  • Age 18 years or above at the time of signing the informed consent
  • Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2)

Who cannot join

  • Glycated haemoglobin (HbA1c) ≥ 6.5 % (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening
  • History of type 1 or type 2 diabetes mellitus

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

United States46 sites

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79124

  • Washington Cntr Weight Mgmt

    Arlington, Virginia, 22206

  • Univ of Colorado at Denver

    Aurora, Colorado, 80045

  • Elligo Clin Res Centre

    Austin, Texas, 78704

  • UT Health University of Texas

    Bellaire, Texas, 77401

  • Univ of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Holston Medical Group_Bristol

    Bristol, Tennessee, 37620

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Medical University Of South Carolina

    Charleston, South Carolina, 29425

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303

  • Hope Clin Res & Wellness

    Conyers, Georgia, 30094

  • FDRC

    Costa Mesa, California, 92627

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864

  • Baylr Sctt White Rs Inst, Endo

    Dallas, Texas, 75226

  • Velocity Clin Res, Dallas

    Dallas, Texas, 75230

  • UT Southwestern Medical Center-CRU

    Dallas, Texas, 75390

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • Medication Mgmnt, LLC_Grnsboro

    Greensboro, North Carolina, 27405

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • Midwest Inst For Clin Res

    Indianapolis, Indiana, 46260

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida, 32216

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605

  • South Broward Research LLC

    Miramar, Florida, 33027

  • Chambliss Clinical Trials LLC

    Montgomery, Alabama, 36106

  • Yale University School Of Medicine

    New Haven, Connecticut, 06519

  • Comprehensive Weight Ctrl Prog

    New York, New York, 10021

  • Health Res of Hampton Roads

    Newport News, Virginia, 23606

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072

  • Coastal Carolina Res Ctr

    North Charleston, South Carolina, 29405

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • The University of Penn Center

    Philadelphia, Pennsylvania, 19104-3317

  • Accellacare_NC

    Raleigh, North Carolina, 27609

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • National Clin Res Inc.

    Richmond, Virginia, 23294

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681-1538

  • Endeavor Health

    Skokie, Illinois, 60077

  • Evanston Premier Hlthcr Res

    Skokie, Illinois, 60077

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • New Venture Medical Research

    Wadsworth, Ohio, 44281

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Accellacare

    Wilmington, North Carolina, 28401

  • Selma Medical Associates

    Winchester, Virginia, 22601-3834

Other trials in United States

About this study

Official title: Efficacy and Safety of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly Compared to Tirzepatide 15 mg s.c. Once-weekly in Participants With Obesity

This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.

Conditions
Obesity
Being tested
Cagrilintide, Semaglutide, Tirzepatide
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CagrilintideDrug

    Cagrilintide will be administered subcutaneously.

  • SemaglutideDrug

    Semaglutide will be administered subcutaneously.

  • TirzepatideDrug

    Tirzepatide will be administered subcutaneously.

Study groups in NCT06131437
Study groupRoleWhat they receive
CagriSema 2.4 mg/2.4 mgExperimentalParticipants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 84 weeks.
Receives: Drug: Cagrilintide; Drug: Semaglutide
Tirzepatide 15 mgActive comparatorParticipants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks.
Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight

    Measured in percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 84)

Secondary outcomes (14)

  1. To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight

    Measured in percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 84)

  2. Achievement of greater than or equal to (≥) 25% weight reduction

    Count of participants.

    Measured: From baseline (week 0) to end of treatment (week 84)

  3. Achievement of ≥ 30% weight reduction

    Count of participants.

    Measured: From baseline (week 0) to end of treatment (week 84)

  4. Change in waist circumference

    Measured in centimeter (cm).

    Measured: From baseline (week 0) to end of treatment (week 84)

  5. Change in systolic blood pressure (SBP)

    Measured in millimeter of mercury (mmHg).

    Measured: From baseline (week 0) to end of treatment (week 84)

  6. Change in diastolic blood pressure (DBP)

    Measured in mmHg.

    Measured: From baseline (week 0) to end of treatment (week 84)

  7. Relative change in lipids: Total cholesterol

    Measured in percentage.

    Measured: From baseline (week 0) to end of treatment (week 84)

  8. Relative change in lipids: High-density lipoprotein (HDL) cholesterol

    Measured in percentage.

    Measured: From baseline (week 0) to end of treatment (week 84)

  9. Relative change in lipids: Non-HDL cholesterol

    Measured in percentage.

    Measured: From baseline (week 0) to end of treatment (week 84)

  10. Relative change in lipids: Low-density lipoprotein (LDL) cholesterol

    Measured in percentage.

    Measured: From baseline (week 0) to end of treatment (week 84)

  11. Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol

    Measured in percentage.

    Measured: From baseline (week 0) to end of treatment (week 84)

  12. Relative change in lipids: Triglycerides

    Measured in percentage.

    Measured: From baseline (week 0) to end of treatment (week 84)

  13. Number of Treatment-emergent Adverse Events (TEAEs)

    Count of events.

    Measured: From baseline (week 0) to end of study (week 90)

  14. Number of Treatment Emergent Serious adverse events (TESAEs)

    Count of events.

    Measured: From baseline (week 0) to end of study (week 90)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start27 Nov 2023
  3. Primary completion8 Dec 2025
  4. Study completion9 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
809 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06131437
Sponsor's protocol ID
NN9838-7832
Other IDs
U1111-1292-4835
Status last verified
Feb 2026
First submitted
9 Nov 2023
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cagrilintide, Semaglutide and Tirzepatide in people with Obesity, run by Novo Nordisk A/S at 46 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 84)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06131437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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