Current partner codePEPTIDESDE
NCT06221969·Phase 3·INTERVENTIONAL

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

Status

Completed

Phase

Phase 3

Enrollment

1,024

Locations

196

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

Interventions

Treatment arms and agents.

DRUG

Cagrilintide

Cagrilintide will be administered subcutaneously.

DRUG

Semaglutide

Semaglutide will be administered subcutaneously.

DRUG

Tirzepatide

Tirzepatide will be administered subcutaneously.

Timeline

From registration to results.

  1. First posted

    Jan 24, 2024

  2. Study start

    Jan 16, 2024

  3. Primary completion

    Mar 4, 2026

  4. Study completion

    Apr 6, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Apr 22, 2026

Outcomes

What the study measures.

Primary outcomes

Change in glycated haemoglobin (HbA1c)

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured in percentage (%)-points.

Relative change in body weight

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured in percentage (%).

Secondary outcomes

Change in HbA1c

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured in %-points.

Change in fasting plasma glucose (FPG)

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured in millimoles per liter (mmol/L).

Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])

Time frame · At end of treatment (week 68)

Count of participant

Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)

Time frame · From baseline (week 0) to end of treatment (week 68)

Count of participant

Achievement of greater than or equal to (≥) 5% weight reduction

Time frame · From baseline (week 0) to end of treatment (week 68)

Count of participant

Achievement of ≥ 10% weight reduction

Time frame · From baseline (week 0) to end of treatment (week 68)

Count of participant

Achievement of ≥ 15 % weight reduction

Time frame · From baseline (week 0) to end of treatment (week 68)

Count of participant

Achievement of ≥ 20 % weight reduction

Time frame · From baseline (week 0) to end of treatment (week 68)

Count of participant

Change in systolic blood pressure

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured in millimeters of mercury(mmHg).

Change in diastolic blood pressure

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured in mmHg.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 ≥ 180 days before screening. * Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor. * HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) of ≥ 30.0 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 \< 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.

Study locations

196 registered sites.

Argentina · Australia · Canada · Colombia · India · South Africa · Taiwan · United States. Showing up to 24 locations stored in the fast local snapshot.

Synexus Clin Res-Birmingham

Birmingham, Alabama, United States

Univ of Alabama_Birmingham

Birmingham, Alabama, United States

Prime Medical Group, LLC

Gilbert, Arizona, United States

Velocity Clinical Research-Phoenix

Phoenix, Arizona, United States

Synexus Rsch /Cnt Phnx Med C

Phoenix, Arizona, United States

Arkansas Clinical Research

Little Rock, Arkansas, United States

Unity Health-Searcy Medical Center

Searcy, Arkansas, United States

Velocity Clin Res-Chula Vista

Chula Vista, California, United States

Headlands Research California, LLC

Escondido, California, United States

Neighborhood Healthcare

Escondido, California, United States

St. Jude Heritage Yorba Linda - Pediatric Ste D

Fullerton, California, United States

Diabetes & Endocrine Specialists - La Mesa

La Mesa, California, United States

Diabetes and Endocrine Specialists - La Mesa

La Mesa, California, United States

Velocity Clin Res San Diego

La Mesa, California, United States

Clinical Trials Research

Lincoln, California, United States

Loma Linda Univ Hlth Cr Endo

Loma Linda, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Desert Oasis Healthcare

Palm Springs, California, United States

Velocity Clin Res - Panorama

Panorama City, California, United States

Western University of Health Sciences

Pomona, California, United States

Endocrinology Josel Cabaccan

San Jose, California, United States

Mills-Peninsula Medical Center

San Mateo, California, United States

NorCal Endocrinology and Internal Medicine

San Ramon, California, United States

Premier Medical Center, Inc.

Toluca Lake, California, United States

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 Cagrilintide.

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.