Current partner codePEPTIDESDE
NCT07357740·Phase 2·INTERVENTIONAL

A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes

Status

Withdrawn

Phase

Phase 2

Enrollment

0

Locations

61

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study is being done to look at how well a study medicine called CagriSema helps people with diabetes lower their blood sugar. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. The study will last for about 38 weeks.

Interventions

Treatment arms and agents.

DRUG

CagriSema

Cagrilintide and Semaglutide will be administered subcutaneously using device 1 or device 2.

DRUG

Placebo CagriSema

Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.

Timeline

From registration to results.

  1. First posted

    Jan 22, 2026

  2. Study start

    Aug 27, 2026

  3. Primary completion

    Aug 25, 2027

  4. Study completion

    Oct 13, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 9, 2026

Outcomes

What the study measures.

Primary outcomes

Change in glycated haemoglobin (HbA1c)

Time frame · Baseline to week 28

Measured as percentage-points (%-points).

Secondary outcomes

Weekly average cagrilintide (total) and semaglutide concentration (Cavg) based on population pharmacokinetic analyses

Time frame · From baseline to week 28

Measured in nanomoles per litre (nmol/L).

Change in HbA1c

Time frame · From baseline to week 28

Measured as %-points.

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame · From baseline to week 35

Measured as count of events.

Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per litre [mmol/L]), confirmed by blood glucose (BG) meter, or severe hypoglycaemic episodes (level 3)

Time frame · From baseline to week 35

Measured as count of episodes.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
64 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

61 registered sites.

Denmark · Greece · Malaysia · Serbia · Slovakia · Spain · Thailand · United States. Showing up to 24 locations stored in the fast local snapshot.

Arkansas Clinical Research

Little Rock, Arkansas, United States

Paradigm Clinical Research

San Diego, California, United States

Encompass Clinical Research_Spring Valley

Spring Valley, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Future Medical Research

Longwood, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Clinical Site Partners Kendall Flourish Research

Miami, Florida, United States

West Orange Endocrinology

Ocoee, Florida, United States

Center for Diab,Obes & Metab

Pembroke Pines, Florida, United States

American Research Centers of Florida

Pembroke Pines, Florida, United States

Hope Clin Res & Wellness

Conyers, Georgia, United States

Elevate Clinical Research

Gurnee, Illinois, United States

Accellacare of Duly Oak Lawn

Oak Lawn, Illinois, United States

KDCILM, LLC & Accellacare US, Inc.

Wilmington, North Carolina, United States

Advanced Medical Research - Maumee

Maumee, Ohio, United States

Clinical Res Collaborative

Cumberland, Rhode Island, United States

Clinical Research Associates

Nashville, Tennessee, United States

The Endocrine Center

Houston, Texas, United States

Radiance Clinical Research

Lampasas, Texas, United States

Quality Research Inc

San Antonio, Texas, United States

Medrasa Clinical Research

Sherman, Texas, United States

Sanos Clinic - Vejle

Vejle, Region Syddanmark, Denmark

Sanos Clinic - Gandrup

Gandrup, Denmark

Sanos Clinic - Herlev

Herlev, Denmark

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.