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

Type 2 Diabetes Clinical Trial

— REIMAGINE 1  

Official title:

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323174
• Other study ID #: NN9388-4895
• Secondary ID: 2022-502677-42U1
• Status: Recruiting
• Phase: Phase 3
• Start date: March 19, 2024
• Est. completion date: November 4, 2025

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: November 4, 2025
• Est. primary completion date: August 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
• Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
• Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.

Locations

Country	Name	City	State
China	Chinese People's Liberation Army General Hospital	Beijing	Beijing
China	Jinan Central Hospital	Ji'Nan	Shandong
China	The Second Affiliated Hospital of Nanjing Medical University_Nanjing	Nanjing	Jiangsu
China	The Affiliated Hospital of Jiangsu University_Zhenjiang	Zhenjiang	Jiangsu
Hungary	Belinus Bt.	Debrecen	Hajdu-Bihar Varmegye
Hungary	Borbánya Praxis E.Ü. Kft.	Nyíregyháza	Szabolcs-Szatmar Varmegye
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Policlinico Mater Domini Università di Catanzaro	Catanzaro
Italy	IRCCS Ospedale San Raffaele Milano	Milano
Italy	Azienda Ospealiero Universitaria Policlinico Umberto I	Roma
Poland	Renew Clinic Bialystok	Bialystok
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Podkarpackie
Poland	NBR Polska Tomasz Klodawski	Warszawa
Saudi Arabia	King Abdulaziz Hospital-Al Ahsa-National Guard	Al Ahsa
Saudi Arabia	National Guard Hospital - Jeddah	Jeddah
Saudi Arabia	King Fahad Medical City	Riyadh
Saudi Arabia	King Khaled University Hospital,King Saud Univ. Med. City	Riyadh
Saudi Arabia	King Salman Bin Abdulaziz Hospital	Riyadh
Serbia	CHC Zvezdara, Clinical department for endocrinology	Belgrade
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	Clinical Hospital Centre Zemun	Belgrade
Serbia	Policlinic for diabetes	Zajecar
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Encore Medical Research LLC	Hollywood	Florida
United States	National Research Institute_Huntington Park	Huntington Park	California
United States	Holston Medical Group	Kingsport	Tennessee
United States	TPMG Clinical Research	Newport News	Virginia
United States	Alliance for Multispec Res	Newton	Kansas
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Northeast Clinical Research of San Antonio	San Antonio	Texas
United States	Southern California Dermatology	Santa Ana	California
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Arcturus Healthcare, PLC	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  China,  Hungary,  Italy,  Poland,  Saudi Arabia,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycated haemoglobin (HbA1c)	Measured as percentage (%)-points.	From baseline (week 0) to end of treatment (week 40)
Secondary	Relative change in body weight	Measured in %.	From baseline (week 0) to end of treatment (week 40)
Secondary	Number of participants who achieve greater than or equal to (>=) 10% body weight reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 40)
Secondary	Number of participants who achieve >=15% body weight reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 40)
Secondary	Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])	Measured as count of participants.	At end of treatment (week 40)
Secondary	Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol)	Measured as count of participants.	At end of treatment (week 40)
Secondary	Change in Fasting Plasma Glucose (FPG)	Measured in millimoles per liter (mmol/L).	From baseline (week 0) to end of treatment (week 40)
Secondary	Number of participants who achieve >=5% body weight reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 40)
Secondary	Number of participants who achieve >=20% body weight reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 40)
Secondary	Change in waist circumference	Measured in centimeters (cm).	From baseline (week 0) to end of treatment (week 40)
Secondary	Change in systolic blood pressure (SBP)	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to end of treatment (week 40)
Secondary	Change in diastolic blood pressure (DBP)	Measured in mmHg.	From baseline (week 0) to end of treatment (week 40)
Secondary	Ratio to baseline in high sensitivity C-reactive protein (hsCRP)	Measured as ratio.	From baseline (week 0) to end of treatment (week 40)
Secondary	Ratio to baseline in lipids: Total cholesterol	Measured as ratio.	From baseline (week 0) to end of treatment (week 40)
Secondary	Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol	Measured as ratio.	From baseline (week 0) to end of treatment (week 40)
Secondary	Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol	Measured as ratio.	From baseline (week 0) to end of treatment (week 40)
Secondary	Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol	Measured as ratio.	From baseline (week 0) to end of treatment (week 40)
Secondary	Ratio to baseline in lipids: Triglycerides	Measured as ratio.	From baseline (week 0) to end of treatment (week 40)
Secondary	Ratio to baseline in lipids: Free fatty acids	Measured as ratio.	From baseline (week 0) to end of treatment (week 40)
Secondary	Ratio to baseline in lipids: Non-HDL cholesterol	Measured as ratio.	From baseline (week 0) to end of treatment (week 40)
Secondary	Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication)	Measured as count of participants.	At end of study (week 52)
Secondary	Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)	Measured as ratio.	From baseline (week 0) to end of treatment (week 40)
Secondary	Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score	Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10.; Higher scores indicate better functional health and well-being. The vitality score range is from 25.6 to 69.1.	From baseline (week 0) to end of treatment (week 40)
Secondary	Change in SF-36v2 score: Physical Component Summary score	Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for physical component summary is 6.1 to 79.7.	From baseline (week 0) to end of treatment (week 40)
Secondary	Change in SF-36v2 score: Mental Component Summary score	Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for mental component summary score is -3.8 to 78.7.	From baseline (week 0) to end of treatment (week 40)
Secondary	Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score	Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36).	From baseline (week 0) to end of treatment (week 40)
Secondary	Change in leptin	Measured in nanograms per milliliter (ng/mL).	From baseline (week 0) to end of treatment (week 40)
Secondary	Change in soluble leptin receptor	Measured in ng/mL.	From baseline (week 0) to end of treatment (week 40)
Secondary	Number of Treatment Emergent Adverse Events (TEAEs)	Measured as count of events.	From baseline (week 0) to end of treatment +7 weeks (week 47)
Secondary	Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter	Measured as count of episodes.	From baseline (week 0) to end of treatment +7 weeks (week 47)
Secondary	Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold	Measured as count of episodes.	From baseline (week 0) to end of treatment + 7 weeks (week 47)