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New combo shot CagriSema shows promise for diabetes and weight loss

NCT ID NCT06323161

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 2 times

Summary

This study tested a new investigational medicine called CagriSema, which combines two drugs (cagrilintide and semaglutide) in one weekly injection. It was given to 274 adults with type 2 diabetes who were already taking daily insulin, with or without metformin. The goal was to see if CagriSema could lower blood sugar and body weight better than a placebo. The study lasted about one year.

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 new once-weekly injection to help people with type 2 diabetes better control blood sugar and lose weight alongside their current insulin therapy.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The combination may cause side effects like nausea or vomiting, and it may not work for everyone. It is an add-on treatment, not a standalone cure.

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

274 people

The number who actually took part.

Started

Mar 2024

Finished

Oct 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 (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus ≥180 days before screening. * On stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram per day (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening. * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * Body Mass Index (BMI) greater than or equal to 25 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening. * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye 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. * Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804, Japan

  • Alliance for Multispec Res

    Newton, Kansas, 67114, United States

  • Ashmed Medi-Centre

    Cape Town, Western Cape, 7760, South Africa

  • Bioclinical Research Alliance

    Miami, Florida, 33155, United States

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing, Beijing Municipality, 100853, China

  • Clinical Research Associates

    Nashville, Tennessee, 37203, United States

  • Clinical Trial Systems (CTC)

    Pretoria, Gauteng, 0186, South Africa

  • DIA - KONTROL s.r.o.

    Levice, 93401, Slovakia

  • Dr Noeth's Practice

    Pretoria, 0002, South Africa

  • Dr Vawda's site

    Durban, KwaZulu-Natal, 4091, South Africa

  • ENRIN, s.r.o.

    Rimavská Sobota, 979 01, Slovakia

  • Elite Research Center

    Flint, Michigan, 48532, United States

  • Endo and Metab Consultants

    Rockville, Maryland, 20852, United States

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031, Japan

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006, Japan

  • H.E.C Science Clinic

    Kanagawa, 235-0045, Japan

  • H.E.C Science Clinic_Internal Medicine, Diabetes

    Kanagawa, 235-0045, Japan

  • Healthcare centre Kragujevac

    Kragujevac, RS, 34000, Serbia

  • Healthcare centre Nis

    Niš, RS, 18000, Serbia

  • Healthcare centre Zvezdara

    Belgrade, RS, 11050, Serbia

  • Hemant Makan

    Johannesburg, Gauteng, 1827, South Africa

  • Holston Medical Group

    Kingsport, Tennessee, 37660, United States

  • Huaihe Hospital of Henan University

    Kaifeng, Henan, 475000, China

  • Huaihe Hospital of Henan University-Endocrinology

    Kaifeng, Henan, 475000, China

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50266, United States

  • Jinan Central Hospital

    Ji'nan, Shandong, 250013, China

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • Kato Clinic of Internal Medicine_Internal Medicine

    Tokyo, 125-0054, Japan

  • Kumanomae Nishimura Naika Clinic_Internal Medicine

    Arakawa-ku, Tokyo, 116-0012, Japan

  • Kunisaki Makoto Clinic

    Fukuoka-shi, Fukuoka, 819-0168, Japan

  • Kyoto University Hospital_Department of Diabetes, Endocr

    Kyoto-shi, Kyoto, 606-8507, Japan

  • LUDIA, s. r. o.

    Spišská Nová Ves, 05201, Slovakia

  • Lenasia Clinical Trial Centre

    Lenasia, Gauteng, 1827, South Africa

  • MOMED, s.r.o

    Kráľovský Chlmec, 077 01, Slovakia

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Manda Memorial Hospital_Internal Medicine

    Sapporo-shi, Hokkaido, Hokkaido, Japan, 060-0062, Japan

  • Minami Akatsuka Clinic_internal medicine

    Mito-shi, Ibaraki, 311-4153, Japan

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113, Japan

  • Oraderumaz (Pty) Ltd

    Bloemfontein, Free State, 9301, South Africa

  • Palm Research Center Inc.

    Las Vegas, Nevada, 89128, United States

  • PlanIt Research, PLLC

    Houston, Texas, 77079, United States

  • Policlinic for diabetes

    Zaječar, 19000, Serbia

  • Prinshof Medical Campus

    Pretoria, Gauteng, 0002, South Africa

  • SIN AZUCAR s.r.o.

    Malacky, 901 01, Slovakia

  • Sasaki Internal Medicine

    Hokkaido, 062-0007, Japan

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai, Shanghai Municipality, 201200, China

  • Simcare Medical Research, LLC

    Sugar Land, Texas, 77478, United States

  • Solaris Clinical Research

    Meridian, Idaho, 83646, United States

  • Synergy Groups Medical

    Houston, Texas, 77061, United States

  • TPMG Clinical Research

    Newport News, Virginia, 23606, United States

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu, 212001, China

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu, 210011, China

  • The Second Affiliated Hospital of Nanjing Medical University_Nanjing

    Nanjing, Jiangsu, 210011, China

  • Tokyo-Eki Center-building Clinic

    Tokyo, 103-0027, Japan

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027, Japan

  • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

    Yamato-shi, Kanagawa, 242-0004, Japan

  • University Clinical Centre Nis

    Niš, RS, 18 000, Serbia

  • University of North Carolina

    Chapel Hill, North Carolina, 27614, United States

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325, United States

  • Valley Research

    Fresno, California, 93720, United States

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230, United States

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