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New combo shot helps east asians shed pounds in major trial

NCT ID NCT05813925

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new medicine called CagriSema (a mix of two drugs) in 331 East Asian adults with obesity or overweight. Participants received a weekly injection for about 1.5 years. The main goal was to see how much weight they lost compared to another drug. The study is complete and may offer a new option for weight management.

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

331 people

The number who actually took part.

Started

Apr 2023

Finished

Mar 2025

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.

Inclusion Criteria: * 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 Exclusion Criteria: 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 * 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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

Obesity or overweight

Contacts and locations

Locations

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804, Japan

  • Fukuwa Clinic

    Tokyo, 104-0031, Japan

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031, Japan

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034, Japan

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

    Numakunai, 020-8505, Japan

  • Kawada Clinic

    Gunma, 373-0036, Japan

  • Minamino Cardiovascular Hospital_Cardiovascular medicine

    Tokyo, 192-0918, Japan

  • Naka Kinen Clinic

    Ibaraki, 311-0113, Japan

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113, Japan

  • National Taiwan University Hospital_main

    Taipei, 100, Taiwan

  • OCROM Clinic_Internal medicine

    Suita-shi, Osaka, 565-0853, Japan

  • Okabe Clinic

    Chuo-ku, Tokyo, 104-0061, Japan

  • Osaka NISHI-UMEDA Clinic

    Osaka, 530-0001, Japan

  • Osaka NISHI-UMEDA Clinic_Internal Medicine

    Osaka, 530-0001, Japan

  • Seino Internal Medicine Clinic_Internal medicine

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

  • Shinden Higashi Clinic

    Sendai-shi, Miyagi, 983-0039, Japan

  • Shinden Higashi Clinic_Internal medicine

    Sendai-shi, Miyagi, 983-0039, Japan

  • Shinsapporo Seiryou Hospital, General Clinical Department

    Sapporo-shi, Hokkaido, 004-0004, Japan

  • Suidoubashi Medical Clinic_Internal Medicine

    Chiyoda-ku, Tokyo, 101-0065, Japan

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009, Japan

  • The Institute of Medical Science, Asahi Life Foundation

    Chuo-ku, Tokyo, 103-0002, Japan

  • The Institute of Medical Science, Asahi Life Foundation_Internal Medicine

    Chuo-ku, Tokyo, 103-0002, Japan

  • The University of Tokyo Hospital, Diabetes and Metabolic

    Bunkyo-ku, Tokyo, 113-8655, Japan

  • ToCROM Clinic_Internal Medicine

    Tokyo, 160-0008, Japan

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027, Japan

  • Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa, 242-0004, Japan

  • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

    Yamato-shi, Kanagawa, 242-0004, Japan

  • Yao Tokushukai General Hospital_Cardiovascular division

    Yao-shi, Osaka, 581-0011, Japan

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