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New diabetes drug combo CagriSema enters phase 2 trial

NCT ID NCT07357740

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study tests a new medicine called CagriSema, which combines two drugs to lower blood sugar in people with type 2 diabetes. About 400 adults aged 18-64 will receive either CagriSema or a placebo using one of two injection devices. The main goal is to see how well it reduces HbA1c levels over 38 weeks.

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 combination of cagrilintide and semaglutide)
What this could lead to
If successful, this could lead to a new treatment option for type 2 diabetes that helps control blood sugar with a convenient injection device.
What could go wrong
This is an early phase 2 trial, so the drug may not work better than existing treatments. Side effects are possible, and the study is not yet recruiting.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 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 to 64 years

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 18-64 years (both inclusive) at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening. * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (%) (53-91 \[millimoles per mole\] mmol/mol) (both inclusive) as determined by the central laboratory at screening. * Stable daily dose \>= 90 days before screening of metformin at effective or maximum tolerated dose as judged by the investigator. * Body mass index (BMI) between 25.0 and 39.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening. Exclusion Criteria: * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 millilitre per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by the central laboratory at screening. * Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) 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. * Previous exposure to CagriSema in a clinical study.

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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

  • Accellacare of Duly Oak Lawn

    Oak Lawn, Illinois, 60453, United States

  • Advanced Medical Research - Maumee

    Maumee, Ohio, 43537, United States

  • Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada

    Manresa, 08243, Spain

  • American Research Centers of Florida

    Pembroke Pines, Florida, 33027, United States

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205, United States

  • Athens Medical Center S.A. (Iatriko Psychicou) - Department of Internal Medicine & Metabolic Diseases

    Athens, 11525, Greece

  • CAP Alhambra

    L'Hospitalet de Llobregat, 08920, Spain

  • CAPSBE_CAP Ernest LLuch

    Barcelona, 08028, Spain

  • CHC Zvezdara, Clinical department for endocrinology

    Belgrade, 11000, Serbia

  • Center for Diab,Obes & Metab

    Pembroke Pines, Florida, 33024, United States

  • Centro Periferico De Especialidades Bola Azul

    Almería, 04009, Spain

  • Centro de Salud Cabra Matrona Antonia Mesa

    Cabra, 14940, Spain

  • Centro de Salud Monzón Urbano

    Monzón, 22400, Spain

  • Centro de Salud Pola de Siero

    Pola de Siero, 33510, Spain

  • Centro de Salud San Juan de la Cruz

    Pozuelo de Alarcón, 28223, Spain

  • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

    Kragujevac, 34000, Serbia

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864, United States

  • Clinical Research Associates

    Nashville, Tennessee, 37203, United States

  • Clinical Site Partners Kendall Flourish Research

    Miami, Florida, 33186, United States

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003, Spain

  • DIALIPID, s.r.o.

    Prešov, 080 01, Slovakia

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • Diakom, spol. s r.o.

    Poprad, 05801, Slovakia

  • EBA Vallcarca SLP

    Barcelona, 08023, Spain

  • Elevate Clinical Research

    Gurnee, Illinois, 60031, United States

  • Encompass Clinical Research_Spring Valley

    Spring Valley, California, 91978, United States

  • Endocrinology, Diabetes and Metabolism Diseases Clinic

    Belgrade, 11000, Serbia

  • Future Medical Research

    Longwood, Florida, 32750, United States

  • General Hospital Of Thessaloniki Papageorgiou - 3rd Department of Internal Medicine

    Efkarpia, 564 29, Greece

  • General University Hospital Of Patras - Endocrinology Department

    Pátrai, 265 04, Greece

  • Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department

    Thessaloniki, 570 10, Greece

  • Hope Clin Res & Wellness

    Conyers, Georgia, 30094, United States

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586, Malaysia

  • Hospital Melaka

    Malacca, 75400, Malaysia

  • Hospital Miri

    Miri, Sarawak, 98000, Malaysia

  • Hospital Seberang Jaya

    Pulau Pinang, 13700, Malaysia

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100, Malaysia

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Ippokratio General Hospital Of Thessaloniki - 2nd Propaedeutic Department of Internal Medicine

    Thessaloniki, 546 42, Greece

  • KDCILM, LLC & Accellacare US, Inc.

    Wilmington, North Carolina, 28401, United States

  • MED-DIA CENTRUM s.r.o.

    Považská Bystrica, 01701, Slovakia

  • MEDIVASA, s.r.o., Diabetologicka ambulancia

    Žilina, 010 01, Slovakia

  • Medrasa Clinical Research

    Sherman, Texas, 75092, United States

  • New Horizon Research Center

    Miami, Florida, 33165, United States

  • Paradigm Clinical Research

    San Diego, California, 92108, United States

  • Phramongkutklao Hospital

    Bangkok, 10400, Thailand

  • Quality Research Inc

    San Antonio, Texas, 78209, United States

  • RIHES-CMU_Research Institute for Health Sciences

    Chiang Mai, 50200, Thailand

  • Radiance Clinical Research

    Lampasas, Texas, 76550, United States

  • Regionshospitalet Viborg - Karkirurgisk Afsnit

    Viborg, 8800, Denmark

  • Sanos Clinic - Gandrup

    Gandrup, 9362, Denmark

  • Sanos Clinic - Herlev

    Herlev, 2730, Denmark

  • Sanos Clinic - Vejle

    Vejle, Region Syddanmark, 7100, Denmark

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Thammasat Hospital_CRC

    Pathum Thani, 12120, Thailand

  • The Endocrine Center

    Houston, Texas, 77079, United States

  • Thermi Clinic S.A. - Diabetes and Internal Medicine Department

    Thessaloniki, 57001, Greece

  • University Clinical Centre Nis

    Niš, 18 000, Serbia

  • West Orange Endocrinology

    Ocoee, Florida, 34761, United States

  • iDia s. r. o.

    Žiar nad Hronom, 965 01, Slovakia

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