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Obesity or OverweightPhase 3NCT05813925

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

A Phase 3 study testing Cagrilintide and Semaglutide in people with Obesity or Overweight, run by Novo Nordisk A/S at 28 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity or Overweight
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
331 participants
Where
28 sitesin 2 countries
Study dates
3 Apr 2023to 7 Mar 2025
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 greater than to or equal 18 years at the time of signing informed consent
  • a) Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m^2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D
  • Diabetes-related for participant with T2D
  • Diagnosed with T2D greater than or equal to 180 days before screening
  • HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening
  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors [AGI], glinides, sodium-glucose cotransporter 2 inhibitor [SGLT2i]), thiazolidinediones, or sulphonylureas [SU] as a single agent or in combination) according to local label
  • Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening

Who cannot join

  • Obesity-related
  • Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
  • Glycaemia-related for participant without T2D
  • HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
  • History of type 1 or type 2 diabetes
  • Diabetes-related for participant with T2D
Show all 9Show fewer
  • Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m^2) as measured by central laboratory at screening
  • Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Trial locations and contacts

28 sites in 2 countries.

28 sites in 2 countries

Japan27 sites

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009

  • The University of Tokyo Hospital, Diabetes and Metabolic

    Bunkyo-ku, Tokyo, 113-8655

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804

  • Suidoubashi Medical Clinic_Internal Medicine

    Chiyoda-ku, Tokyo, 101-0065

  • The Institute of Medical Science, Asahi Life Foundation_Internal Medicine

    Chuo-ku, Tokyo, 103-0002

  • The Institute of Medical Science, Asahi Life Foundation

    Chuo-ku, Tokyo, 103-0002

  • Okabe Clinic

    Chuo-ku, Tokyo, 104-0061

  • Kawada Clinic

    Gunma, 373-0036

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

  • Naka Kinen Clinic

    Ibaraki, 311-0113

  • Seino Internal Medicine Clinic_Internal medicine

    Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034

  • Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine

    Numakunai, 020-8505

  • Osaka NISHI-UMEDA Clinic_Internal Medicine

    Osaka, 530-0001

  • Osaka NISHI-UMEDA Clinic

    Osaka, 530-0001

  • Shinsapporo Seiryou Hospital, General Clinical Department

    Sapporo-shi, Hokkaido, 004-0004

  • Shinden Higashi Clinic_Internal medicine

    Sendai-shi, Miyagi, 983-0039

  • Shinden Higashi Clinic

    Sendai-shi, Miyagi, 983-0039

  • OCROM Clinic_Internal medicine

    Suita-shi, Osaka, 565-0853

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031

  • Fukuwa Clinic

    Tokyo, 104-0031

  • ToCROM Clinic_Internal Medicine

    Tokyo, 160-0008

  • Minamino Cardiovascular Hospital_Cardiovascular medicine

    Tokyo, 192-0918

  • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

    Yamato-shi, Kanagawa, 242-0004

  • Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa, 242-0004

  • Yao Tokushukai General Hospital_Cardiovascular division

    Yao-shi, Osaka, 581-0011

Other trials in Japan

Taiwan1 site

  • National Taiwan University Hospital_main

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Efficacy and Safety of Cagrilintide S.C. 2.4 mg in Combination With Semaglutide S.C. 2.4 mg (CagriSema S.C. 2.4 mg/2.4 mg) Once-Weekly in East Asian Participants With Overweight or Obesity

This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.

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

What participants receive

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

  • CagrilintideDrug

    Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks

  • SemaglutideDrug

    Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks for 52 weeks

  • Placebo SemaglutideDrug

    Participants will receive placebo matched to semaglutide

Study groups in NCT05813925
Study groupRoleWhat they receive
CagriSema 2.4 mg/2.4 mgExperimentalParticipants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly (OW) after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks
Receives: Drug: Cagrilintide; Drug: Semaglutide
Semaglutide 2.4 mgActive comparatorParticipants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks
Receives: Drug: Semaglutide; Drug: Placebo Semaglutide

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)

Secondary outcomes (25)

  1. Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent

    Measured as count of participants

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

  2. Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline

    Measured in centimeter (cm)

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

  3. Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population

    Measured as percentage point

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

  4. Change in VFA Measured by CT Scan in Subset of the Japanese Study Population

    Measured in centimeter square (cm^2)

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

  5. Number of Participants Who Achieve (Yes/No): VFA lesser than 100 cm^2 (Only for Participants with VFA greater than or equal to 100 cm^2 at Baseline)

    Measured as count of participants

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

  6. Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent

    Measured as count of participants

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

  7. Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent

    Measured as count of participants

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

  8. Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent

    Measured as count of participants

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

  9. Relative Change in Body Weight

    Measured in percentage (%)

    Measured: From baseline (week 0) to week 20

  10. Change in Body Weight

    Measured in kilogram (kg)

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

  11. Change in Body Mass Index (BMI)

    Measured in kilogram per meter square (kg/m^2)

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

  12. Change in Glycated Haemoglobin (HbA1c)

    Measured in percentage points

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

  13. Change in Fasting Plasma Glucose (FPG)

    Measured as millimole per liter (mmol/L)

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

  14. Change in Fasting Insulin

    Measured as milliunits per liter (mU/L)

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

  15. Change in Systolic Blood Pressure (SBP)

    Measured in millimeter of mercury (mmHg)

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

  16. Change in Diastolic Blood Pressure (DBP)

    Measured in millimeter of mercury (mmHg)

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

  17. Change in Total Cholesterol

    Measured in percentage (%)

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

  18. Change in High-Density Lipoprotein (HDL) Cholesterol

    Measured in percentage (%)

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

  19. Change in Low-Density Lipoprotein (LDL) Cholesterol

    Measured in percentage (%)

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

  20. Change in Very Low-Density Lipoprotein (VLDL)

    Measured in percentage (%)

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

  21. Change in Triglycerides

    Measured in percentage (%)

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

  22. Change in Free fatty Acids

    Measured in percentage (%)

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

  23. Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT) Physical Function Score

    IWQOL-Lite-CT is a 20-item patient reported outcome (PRO) instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score

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

  24. Number of Treatment-Emergent Adverse Events (TEAEs)

    Measured as count of events

    Measured: From baseline (week 0) to end of study (week 75)

  25. Number of Serious Adverse Events (SAEs)

    Measured as count of events

    Measured: From baseline (week 0) to end of study (week 75)

Timeline

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

  1. First posted14 Apr 2023
  2. Study start3 Apr 2023
  3. Primary completion17 Jan 2025
  4. Study completion7 Mar 2025

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
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05813925
Sponsor's protocol ID
NN9838-4762
Other IDs
U1111-1277-3764, jRCT2031220734
Status last verified
Jan 2026
First submitted
3 Apr 2023
Last updated
22 Jan 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

Publications

  • Yamauchi T, Becker NP, Hagemann CA, Huang KC, Kiyosue A, Lim S, Onishi Y, Kosuvaripalli A, Takano T, Ishigaki Y; REDEFINE 5 study group. Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2026 Jun;14(6):450-462. doi: 10.1016/S2213-8587(25)00402-4. Epub 2026 Apr 17.

    PubMed 42009015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cagrilintide and Semaglutide in people with Obesity or Overweight, run by Novo Nordisk A/S at 28 sites in 2 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 8 inclusion and 9 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Japan, Taiwan. 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?

Relative Change in Body Weight (time frame: From baseline (week 0) to end of treatment (week 68)). 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 NCT05813925, which also lists 1 linked publication.

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 22 Jan 2026.

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