Current partner codePEPTIDESDE
NCT06323161·Phase 3·INTERVENTIONAL

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin

Status

Completed

Phase

Phase 3

Enrollment

274

Locations

53

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

This study will look at how much 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 "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.

Interventions

Treatment arms and agents.

DRUG

Cagrilintide

Participants will receive once-weekly cagrilintide subcutaneously.

DRUG

Semaglutide

Participants will receive once-weekly semaglutide subcutaneously.

DRUG

Placebo

Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.

Timeline

From registration to results.

  1. First posted

    Mar 21, 2024

  2. Study start

    Mar 26, 2024

  3. Primary completion

    Sep 9, 2025

  4. Study completion

    Oct 23, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Nov 28, 2025

Outcomes

What the study measures.

Primary outcomes

Change in Glycated Haemoglobin (HbA1c)

Time frame · From baseline (week 0) to end of treatment (week 40)

Measured in percentage (%)- points.

Secondary outcomes

Relative Change in Body Weight

Time frame · From baseline (week 0) to end of treatment (week 40)

Measured in percentage (%).

Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction

Time frame · From baseline (week 0) to end of treatment (week 40)

Measured as count of participants.

Number of Participants Who Achieve ≥15% Body Weight Reduction

Time frame · From baseline (week 0) to end of treatment (week 40)

Measured as count of participants.

Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol])

Time frame · At end of treatment (week 40)

Measured as count of participants.

Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol)

Time frame · At end of treatment (week 40)

Measured as count of participants.

Change in Fasting Plasma Glucose (FPG)

Time frame · From baseline (week 0) to end of treatment (week 40)

Measured as millimole per liter (mmol/L).

Change in Insulin Dose

Time frame · From baseline (week 0) to end of treatment (week 40)

Measured in units (u).

Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units

Time frame · At end of treatment (week 40)

Measured as count of participants.

Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals)

Time frame · From baseline (week 0) to end of treatment (week 40)

Measured in mmol/L.

Number of Participants Who Achieve ≥5% Body Weight Reduction

Time frame · From baseline (week 0) to end of treatment (week 40)

Measured as count of participants.

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 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.

Study locations

53 registered sites.

China · Japan · Serbia · Slovakia · South Africa · United States. Showing up to 24 locations stored in the fast local snapshot.

Valley Clinical Trials, Inc.

Northridge, California, United States

Bioclinical Research Alliance

Miami, Florida, United States

Solaris Clinical Research

Meridian, Idaho, United States

Iowa Diab & Endo Res Center

West Des Moines, Iowa, United States

Alliance for Multispec Res

Newton, Kansas, United States

Elite Research Center

Flint, Michigan, United States

Palm Research Center Inc.

Las Vegas, Nevada, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Clinical Research Associates

Nashville, Tennessee, United States

Velocity Clinical Res-Dallas

Dallas, Texas, United States

Synergy Groups Medical

Houston, Texas, United States

PlanIt Research, PLLC

Houston, Texas, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

TPMG Clinical Research

Newport News, Virginia, United States

Chinese People's Liberation Army General Hospital-Endocrinology

Beijing, Beijing Municipality, China

Huaihe Hospital of Henan University-Endocrinology

Kaifeng, Henan, China

Huaihe Hospital of Henan University

Kaifeng, Henan, China

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanjing Medical University_Nanjing

Nanjing, Jiangsu, China

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, China

Jinan Central Hospital

Ji'nan, Shandong, China

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, China

Shanghai Pudong New Area People's Hospital-Endocrinology

Shanghai, Shanghai Municipality, China

Manda Memorial Hospital_Internal Medicine

Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan

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.