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

NCT06323161 | Completed Phase 3 FDA Drug

• 3 other identifiers: NN9388-7637U1111-1283-07542022-502679-43
• Study Type: interventional
• Target: 274
• Locations: 6 countries
• Sites: 53

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Haemoglobin (HbA1c)

  Measured in percentage (%)- points.

  From baseline (week 0) to end of treatment (week 40)

Secondary Outcomes (31)

• Relative Change in Body Weight

  From baseline (week 0) to end of treatment (week 40)

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

  From baseline (week 0) to end of treatment (week 40)

• Number of Participants Who Achieve ≥15% Body Weight Reduction

  From baseline (week 0) to end of treatment (week 40)

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

  At end of treatment (week 40)

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

  At end of treatment (week 40)

Study Arms (4)

CagriSema Dose 1

ACTIVE COMPARATOR

Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.

Drug: Cagrilintide; Drug: Semaglutide

CagriSema Dose 2

ACTIVE COMPARATOR

Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.

Drug: Cagrilintide; Drug: Semaglutide

Placebo Dose 1

PLACEBO COMPARATOR

Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 40 weeks.

Drug: Placebo

Placebo Dose 2

PLACEBO COMPARATOR

Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 40 weeks

Drug: Placebo

Interventions

Cagrilintide DRUG

Participants will receive once-weekly cagrilintide subcutaneously.

CagriSema Dose 1; CagriSema Dose 2

Semaglutide DRUG

Participants will receive once-weekly semaglutide subcutaneously.

CagriSema Dose 1; CagriSema Dose 2

Placebo DRUG

Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.

Placebo Dose 1; Placebo Dose 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (53)

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

Bioclinical Research Alliance

Miami, Florida, 33155, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Iowa Diab & Endo Res Center

West Des Moines, Iowa, 50266, United States

Location

Alliance for Multispec Res

Newton, Kansas, 67114, United States

Location

Elite Research Center

Flint, Michigan, 48532, United States

Location

Palm Research Center Inc.

Las Vegas, Nevada, 89128, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27614, United States

Location

Clinical Research Associates

Nashville, Tennessee, 37203, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

Synergy Groups Medical

Houston, Texas, 77061, United States

Location

PlanIt Research, PLLC

Houston, Texas, 77079, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

TPMG Clinical Research

Newport News, Virginia, 23606, United States

Location

Chinese People's Liberation Army General Hospital-Endocrinology

Beijing, Beijing Municipality, 100853, China

Location

Huaihe Hospital of Henan University-Endocrinology

Kaifeng, Henan, 475000, China

Location

Huaihe Hospital of Henan University

Kaifeng, Henan, 475000, China

Location

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, 210011, China

Location

The Second Affiliated Hospital of Nanjing Medical University_Nanjing

Nanjing, Jiangsu, 210011, China

Location

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, 212001, China

Location

Jinan Central Hospital

Ji'nan, Shandong, 250013, China

Location

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, 250013, China

Location

Shanghai Pudong New Area People's Hospital-Endocrinology

Shanghai, Shanghai Municipality, 201200, China

Location

Manda Memorial Hospital_Internal Medicine

Sapporo-shi, Hokkaido, Hokkaido, Japan, 060-0062, Japan

Location

Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, Kanagawa, 242-0004, Japan

Location

Kumanomae Nishimura Naika Clinic_Internal Medicine

Arakawa-ku, Tokyo, 116-0012, Japan

Location

Akaicho Clinic

Chiba-shi, Chiba, 260-0804, Japan

Location

Futata Tetsuhiro Clinic Meinohama_Internal medicine

Fukuoka-shi, Fukuoka, 819-0006, Japan

Location

Kunisaki Makoto Clinic

Fukuoka-shi, Fukuoka, 819-0168, Japan

Location

Sasaki Internal Medicine

Hokkaido, 062-0007, Japan

Location

Naka Kinen Clinic_Internal medicine

Ibaraki, 311-0113, Japan

Location

H.E.C Science Clinic

Kanagawa, 235-0045, Japan

Location

Kyoto University Hospital

Kyoto-shi, Kyoto, 606-8507, Japan

Location

Minami Akatsuka Clinic

Mito-shi, Ibaraki, 311-4153, Japan

Location

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, 103-0027, Japan

Location

Tokyo-Eki Center-building Clinic

Tokyo, 103-0027, Japan

Location

Fukuwa Clinic_Internal Medicine

Tokyo, 104-0031, Japan

Location

Kato Clinic of Internal Medicine_Internal Medicine

Tokyo, 125-0054, Japan

Location

Healthcare centre Zvezdara

Belgrade, RS, 11050, Serbia

Location

Healthcare centre Kragujevac

Kragujevac, RS, 34000, Serbia

Location

University Clinical Centre Nis

Niš, RS, 18 000, Serbia

Location

Healthcare centre Nis

Niš, RS, 18000, Serbia

Location

Policlinic for diabetes

Zaječar, 19000, Serbia

Location

MOMED, s.r.o

Kráľovský Chlmec, 077 01, Slovakia

Location

DIA - KONTROL s.r.o.

Levice, 93401, Slovakia

Location

SIN AZUCAR s.r.o.

Malacky, 901 01, Slovakia

Location

ENRIN, s.r.o.

Rimavská Sobota, 979 01, Slovakia

Location

LUDIA, s. r. o.

Spišská Nová Ves, 05201, Slovakia

Location

Oraderumaz (Pty) Ltd

Bloemfontein, Free State, 9301, South Africa

Location

Lenasia Clinical Trial Centre

Lenasia, Gauteng, 1827, South Africa

Location

Prinshof Medical Campus

Pretoria, Gauteng, 0002, South Africa

Location

Clinical Trial Systems (CTC)

Pretoria, Gauteng, 0186, South Africa

Location

Ashmed Medi-Centre

Cape Town, Western Cape, 7760, South Africa

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

cagrilintide; semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: March 26, 2024
• Primary Completion: September 9, 2025
• Study Completion: October 23, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (9); JP (15); US (14); SL (5); ZA (5); SE (5)