Can a weekly Two-Drug shot replace semaglutide for type 2 diabetes?

NCT ID NCT07817251

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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
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Status unknown
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First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing how safely and comfortably people with type 2 diabetes can switch from semaglutide to CagriSema, a weekly injection that combines cagrilintide and semaglutide. About 210 adults who have taken a stable dose of branded semaglutide for at least three months will receive CagriSema for roughly six months. The study tracks side effects and low blood sugar episodes to see how well participants tolerate the change.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CagriSema, a weekly injection that combines cagrilintide and semaglutide
What this could lead to
If it works, people with type 2 diabetes who already take semaglutide could have a clear path to a newer combination treatment without stopping therapy.
What could go wrong
This is a safety and tolerability study, not a test of whether the switch improves blood sugar. The trial may show that switching causes side effects that make it impractical, and the results may not apply to everyone with type 2 diabetes.

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

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

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 assigned at birth, inclusive of all gender identities). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus (T2DM) greater than or equal to (≥) 180 days before screening. * Stable once-weekly dose ≥ 90 days before screening of branded s.c. semaglutide. Branded semaglutide s.c. includes Ozempic and Wegovy. Participants on compounded semaglutide are ineligible. * Not on treatment with oral antidiabetic drugs or on stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen at effective or maximum tolerated dose (MTD) as judged by the investigator: metformin and/or sodiumglucose co-transporter-2 (SGLT2) inhibitor. * Glycated haemoglobin (HbA1c) 6.5-10.5 percentage (%) (48-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) ≥ 25 kilograms 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 from screening. * Renal impairment with estimated glomerular filtration rate (eGFR) less than (\<) 30 milliliter 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. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * 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. * A self-reported change in body weight \> 5% within 90 days before screening irrespective of medical records. * Use of personal continuous glucose monitoring (CGM) devices. Participants currently using personal CGM devices must discontinue use prior to screening and throughout study participation.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    40 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AGA Clinical Trial

    Hialeah, Florida, 33012, United States

  • Accellacare Wilmington

    Wilmington, North Carolina, 28401, United States

  • Adult Medicine of Lake County, Inc

    Mt. Dora, Florida, 32757, United States

  • Advanced Medical Research

    Maumee, Ohio, 43537, United States

  • Albuquerque Clinical Trials Inc.

    Albuquerque, New Mexico, 87102, United States

  • Alliance for Multispecialty Research

    Newton, Kansas, 67114, United States

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79124, United States

  • Ark Clinical Research

    Fountain Valley, California, 92708, United States

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708, United States

  • Chrysalis Clinical Research

    St. George, Utah, 84790, United States

  • Clinical Research Associates

    Nashville, Tennessee, 37203, United States

  • Clinical Trials Research_Sacramento

    Sacramento, California, 95821, United States

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606, United States

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605, United States

  • Diabetes & Endo Treatment Spec

    Sandy City, Utah, 84093, United States

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76132, United States

  • Downtown LA Res Ctr. Inc.

    Los Angeles, California, 90017, United States

  • Dream Team Clinical Research

    Pomona, California, 91767, United States

  • East West Med Res Inst

    Honolulu, Hawaii, 96814, United States

  • Endeavor Health

    Skokie, Illinois, 60077, United States

  • Gilbert Center For Family Medicine

    Gilbert, Arizona, 85296, United States

  • Iowa Diabetes & Endo Res Ctr

    West Des Moines, Iowa, 50266, United States

  • J.Lewis Research Inc

    Salt Lake City, Utah, 84109, United States

  • JCCT- Juno NW Houston

    Houston, Texas, 77040, United States

  • Linda Vista Health Care Ctr

    San Diego, California, 92111, United States

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401, United States

  • NE Clin Res of San Antonio

    San Antonio, Texas, 78233, United States

  • North Hills Medical Research Inc

    North Richland Hills, Texas, 76180, United States

  • North Texas Endocrine Center

    Dallas, Texas, 75231, United States

  • Northeast Research Institute

    Fleming Island, Florida, 32003, United States

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620, United States

  • Optimal Research Sites

    Orange City, Florida, 32763, United States

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89128, United States

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408, United States

  • Sante Clinical Research

    Kerrville, Texas, 78028, United States

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037, United States

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78749, United States

  • Thrive Clinical Research Group

    Glendora, California, 91740, United States

  • Tidewater Physicians Multispecialty Group

    Newport News, Virginia, 23606, United States

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325, United States

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