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ObesityPhase 3NCT06388187

A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

A Phase 3 study testing Cagrilintide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 25 sites in 5 countries.

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 helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be 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 and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
25 sitesin 5 countries
Study dates
24 Jun 2024to 22 Apr 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 above or equal to 18 years at the time of signing informed consent
  • Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m^2) or
  • BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

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

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

United States7 sites

  • Washington Cntr Weight Mgmt

    Arlington, Virginia, 22206

  • Aurora FDRC Inc.

    Costa Mesa, California, 92627

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • Midwest Inst For Clin Res

    Indianapolis, Indiana, 46260

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • Clinical Trial Res Assoc,Inc

    Plantation, Florida, 33324

  • Accellacare

    Wilmington, North Carolina, 28401

Other trials in United States

United Kingdom6 sites

  • The Health Centre

    Bradford on Avon, BA15 1DQ

  • Southmead Hospital

    Bristol, BS10 5NB

  • Addenbrooke's Hospital_Cambridge

    Cambridge, CB2 0QQ

  • University Hospital Coventry - WISDEM Centre

    Coventry, CV2 2DX

  • Staploe Medical Centre

    Soham, CB7 5JD

  • Joint Clinical Research Facility - Swansea

    Swansea, SA2 8PP

Other trials in United Kingdom

Germany5 sites

  • InnoDiab Forschung GmbH

    Essen, 45136

  • Wendisch - Dahl Hamburg - DZHW

    Hamburg, 22607

  • AmBeNet GmbH

    Leipzig, 04107

  • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

    Münster, 48145

  • Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann

    Witten, 58455

Other trials in Germany

France4 sites

  • Hospices Civils de Lyon-Hopital Lyon Sud-1

    Pierre-Bénite, 69310

  • Hospices Civils de Lyon-Hopital Lyon Sud

    Pierre-Bénite, 69310

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec

    Saint-Herblain, 44800

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil

    Toulouse, 31059

Other trials in France

Canada3 sites

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 1V7

  • Wharton Medical Clinic Clinical Trials (Hamilton)

    Hamilton, Ontario, L8L 5G8

  • Ocean West Research Clinic

    Surrey, British Columbia, V3Z 2N6

Other trials in Canada

About this study

Official title: Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c.(CagriSema s.c. 1.0 mg/1.0 mg and 1.7 mg/1.7 mg) Once-weekly in Participants With Overweight or Obesity

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.

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

What participants receive

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

  • CagrilintideDrug

    Participants will receive once-weekly cagrilintide subcutaneously.

  • SemaglutideDrug

    Participants will receive once-weekly semaglutide subcutaneously.

  • PlaceboDrug

    Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.

Study groups in NCT06388187
Study groupRoleWhat they receive
CagriSema Dose 1ExperimentalParticipants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks.
Receives: Drug: Cagrilintide; Drug: Semaglutide
Placebo Dose 1Placebo comparatorParticipants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks.
Receives: Drug: Placebo
CagriSema Dose 2Active comparatorParticipants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.
Receives: Drug: Cagrilintide; Drug: Semaglutide
Placebo Dose 2Placebo comparatorParticipants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Relative change in body weight

    Measured in percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 68)

  2. Achievement of ≥5% weight reduction

    Measured as count of participant.

    Measured: From baseline (week 0) to end of treatment (week 68)

Secondary outcomes (13)

  1. Achievement of ≥10% weight reduction

    Measured as count of participant.

    Measured: From baseline (week 0) to end of treatment (week 68)

  2. Achievement of ≥15% weight reduction

    Measured as count of participant.

    Measured: From baseline (week 0) to end of treatment (week 68)

  3. Achievement of ≥20% weight reduction

    Measured as count of participant.

    Measured: From baseline (week 0) to end of treatment (week 68)

  4. Change in waist circumference

    Measured in centimeter (cm).

    Measured: From baseline (week 0) to end of treatment (week 68)

  5. Change in systolic blood pressure

    Measured in millimeters of mercury.

    Measured: From baseline (week 0) to end of treatment (week 68)

  6. Ratio to baseline in lipids: Total cholesterol

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  7. Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  8. Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  9. Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  10. Ratio to baseline in lipids: Triglycerides

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  11. Ratio to baseline in lipids: Free fatty acids

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  12. Number of treatment emergent adverse events (TEAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 74)

  13. Number of treatment emergent serious adverse events (TESAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 74)

Timeline

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

  1. First posted29 Apr 2024
  2. Study start24 Jun 2024
  3. Primary completion22 Apr 2026
  4. Study completion22 Apr 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06388187
Sponsor's protocol ID
NN9838-7749
Other IDs
U1111-1298-3451, 2023-509273-24, 2023
Status last verified
May 2026
First submitted
24 Apr 2024
Last updated
5 May 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 and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 25 sites in 5 countries.

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 4 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, United Kingdom, Germany, France, Canada. 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. Some participants in this study may receive a placebo. 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?

Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 68)). The study lists 2 primary outcomes in all. 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 NCT06388187.

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 5 May 2026.

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