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 Diet and Exercise

NCT06323174 | Completed Phase 3 FDA Drug

• 3 other identifiers: NN9388-48952022-502677-42U1111-1283-0404
• Study Type: interventional
• Target: 189
• Locations: 7 countries
• Sites: 50

Brief Summary

This study will look at how much CagriSema helps participants 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. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. 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 as percentage (%)-points.

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

Secondary Outcomes (30)

• 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 millimoles 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 2

ACTIVE COMPARATOR

Participants will receive once-weekly subcutaneous (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 2

PLACEBO COMPARATOR

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

Drug: Placebo

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

Placebo Dose 1

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Semaglutide DRUG

Participants will receive once-weekly semaglutide subcutaneously.

CagriSema Dose 2; Cagrisema Dose 1

Cagrilintide DRUG

Participants will receive once-weekly cagrilintide subcutaneously.

CagriSema Dose 2; Cagrisema Dose 1

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
• Age 18 years or above at the time of signing the informed consent
• Diagnosed with type 2 diabetes \>=30 days before screening
• HbA1c 7.0-9.5 percent (53-80 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening
• Body mass index (BMI) \>=23 kilograms 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 less than 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 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
• History of use of any injectable therapy for diabetes or obesity. 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 a fundus 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (50)

Nat Res Inst Huntington Park

Huntington Park, California, 90255, United States

Location

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

Southern California Dermatology

Santa Ana, California, 92701, United States

Location

Encore Medical Research LLC

Hollywood, Florida, 33024, United States

Location

Headlands Research Orlando

Orlando, Florida, 32819, United States

Location

Encore Medical Research of Weston

Weston, Florida, 33331, United States

Location

Alliance for Multispec Res

Newton, Kansas, 67114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Arcturus HC PLC Troy Med Res

Troy, Michigan, 48098, United States

Location

Southgate Medical Group, LLP

West Seneca, New York, 14224, United States

Location

Summit Research Network Oregon Inc.

Portland, Oregon, 97210, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Amarillo Medical Specialists

Amarillo, Texas, 79124, United States

Location

Elligo Clin Res Centre

Austin, Texas, 78704, United States

Location

Headlands Research Brownsville

Brownsville, Texas, 78526, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

Northeast Clinical Research of San Antonio

San Antonio, Texas, 78233, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Sugar Lakes Family Practice PA

Sugar Land, Texas, 77479, United States

Location

Valley Diab. & Endo Comp Ctr

Weslaco, Texas, 78596, 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

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, 210011, China

Location

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, 212001, China

Location

Jinan Central Hospital

Ji'Nan, Shandong, 250000, China

Location

Jinan Central Hospital

Jinan, Shandong, 250000, China

Location

Belinus Bt.

Debrecen, Hajdú-Bihar, 4025, Hungary

Location

Borbánya Praxis E.Ü. Kft.

Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405, Hungary

Location

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, 1032, Hungary

Location

PVN Kutató Kft.

Budapest, 1102, Hungary

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Policlinico Mater Domini Università di Catanzaro

Catanzaro, 88100, Italy

Location

IRCCS Ospedale San Raffaele Milano

Milan, 20132, Italy

Location

Azienda Ospealiero Universitaria Policlinico Umberto I

Roma, 00161, Italy

Location

Centrum Medyczne Medyk Sp. z o.o.

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

Osteo-Medic s.c. A. Racewicz, J. Supronik

Bialystok, 15-351, Poland

Location

Renew Clinic Sp. z o.o.

Bialystok, 15-797, Poland

Location

Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

Lodz, 90-338, Poland

Location

NBR Polska Tomasz Klodawski

Warsaw, 00-710, Poland

Location

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

Warsaw, 02-507, Poland

Location

Velocity Nova Sp. z o.o.

Zamość, 22-400, Poland

Location

King Abdulaziz Hospital-Al Ahsa-National Guard

Al Ahsa, 36428, Saudi Arabia

Location

National Guard Hospital - Jeddah

Jeddah, 21423, Saudi Arabia

Location

King Fahad Medical City

Riyadh, 11525, Saudi Arabia

Location

King Khaled University Hospital,King Saud Univ. Med. City

Riyadh, 12372, Saudi Arabia

Location

King Salman Bin Abdulaziz Hospital

Riyadh, 12769, Saudi Arabia

Location

CHC Zvezdara, Clinical department for endocrinology

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11080, Serbia

Location

Clinical Hospital Centre Zemun

Belgrade, 11080, Serbia

Location

Policlinic for diabetes

Zaječar, 19000, Serbia

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 19, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 22, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

SE (4); US (21); HU (4); CN (5); IT (4); PL (7); SA (5)