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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06065540




Registration number
NCT06065540
Ethics application status
Date submitted
26/09/2023
Date registered
4/10/2023
Date last updated
7/06/2024

Titles & IDs
Public title
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
Scientific title
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
Secondary ID [1] 0 0
U1111-1283-0427
Secondary ID [2] 0 0
NN9388-4896
Universal Trial Number (UTN)
Trial acronym
REIMAGINE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cagrilintide
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo cagrilintide
Treatment: Drugs - Placebo semaglutide

Experimental: CagriSema 2.4 mg/2.4 mg - Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Experimental: CagriSema 1.0 mg/1.0 mg - Participants will receive once-weekly s.c injections of 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.

Active Comparator: Semaglutide 2.4 mg - Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 68 weeks.

Active Comparator: Semaglutide 1.0 mg - Participants will receive once-weekly s.c injection of 1.0 mg semaglutide for 68 weeks.

Active Comparator: Cagrilintide 2.4 mg - Participants will receive once-weekly s.c injection of 2.4 mg cagrilintide for 68 weeks.

Placebo Comparator: Placebo 2.4 mg/2.4 mg - Participants will receive once-weekly s.c injection of placebo matched to 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Placebo Comparator: Placebo 1.0 mg/1.0 mg - Participants will receive once-weekly s.c injection of placebo matched to 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.


Treatment: Drugs: Cagrilintide
Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of cagrilintide is reached.

Treatment: Drugs: Semaglutide
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.

Treatment: Drugs: Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.

Treatment: Drugs: Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Change in glycated haemoglobin (HbA1c)
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 68)
Primary outcome [2] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Relative change in body weight
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [1] 0 0
CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg: Change in HbA1c
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [2] 0 0
CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg: Relative change in body weight
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [3] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 1.0 mg: Change in HbA1c
Timepoint [3] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [4] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 1.0 mg: Relative change in body weight
Timepoint [4] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [5] 0 0
Cagrilintide 2.4 mg versus placebo: Change in HbA1c
Timepoint [5] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [6] 0 0
Cagrilintide 2.4 mg versus placebo: Relative change in body weight
Timepoint [6] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [7] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of greater than or equal to (>=) 10 percent (%) weight reduction
Timepoint [7] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [8] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of >= 15 % weight reduction
Timepoint [8] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [9] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of >= 20 % weight reduction
Timepoint [9] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [10] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time in Tight Target Range (TITR) 3.9-7.8 millimoles per litre (mmol/L) (70-140 milligrams per decilitre [mg/dL])
Timepoint [10] 0 0
From baseline (week -3) to end of treatment (week 68)
Secondary outcome [11] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Systolic Blood Pressure (SBP)
Timepoint [11] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [12] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in triglycerides
Timepoint [12] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [13] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in non-High Density Lipoprotein (HDL) cholesterols
Timepoint [13] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [14] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in Time In Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)
Timepoint [14] 0 0
From baseline (week -3) to end of treatment (week 68)
Secondary outcome [15] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)
Timepoint [15] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [16] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Fasting Plasma Glucose (FPG)
Timepoint [16] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [17] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])
Timepoint [17] 0 0
At end of treatment (week 68)
Secondary outcome [18] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of HbA1c target values of less than or equal to (=)6.5% (=48 mmol/mol)
Timepoint [18] 0 0
At end of treatment (week 68)
Secondary outcome [19] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time above range, >10.0 mmol/L (>180 mg/dL)
Timepoint [19] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [20] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time above range, >13.9 mmol/L (>250 mg/dL)
Timepoint [20] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [21] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Within-day glycaemic variability (% coefficient of variation [CV])
Timepoint [21] 0 0
At end of treatment (week 68)
Secondary outcome [22] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Achievement of = 5 % weight reduction
Timepoint [22] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [23] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in waist circumference
Timepoint [23] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [24] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Diastolic Blood Pressure (DBP)
Timepoint [24] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [25] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in total cholesterol
Timepoint [25] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [26] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in HDL cholesterol
Timepoint [26] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [27] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in low-density lipoprotein (LDL) cholesterol
Timepoint [27] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [28] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in very low-density lipoprotein (VLDL) cholesterol
Timepoint [28] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [29] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in free fatty acids
Timepoint [29] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [30] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Short Form (SF)-36v score- Physical component summary score
Timepoint [30] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [31] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in SF-36v2 score- Mental component summary score
Timepoint [31] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [32] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score
Timepoint [32] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [33] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Treatment Related Impact Measure for Diabetes (TRIM-D) score
Timepoint [33] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [34] 0 0
CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of treatment emergent adverse events (TEAEs)
Timepoint [34] 0 0
From baseline (week 0) to end of study (week 75)
Secondary outcome [35] 0 0
CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Timepoint [35] 0 0
From baseline (week 0) to end of study (week 75)
Secondary outcome [36] 0 0
CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of severe hypoglycaemic episodes (level 3)
Timepoint [36] 0 0
From baseline (week 0) to end of study (week 75)

Eligibility
Key inclusion criteria
- Male or female.

- Age 18 years or above at the time of signing the informed consent.

- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before
screening.

- Stable daily dose(s) greater than or equal to 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 Sodium-Glucose
Cotransporter-2 (SGLT2) inhibitors.

- 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 metre ( kg/m^2)
at screening. BMI will be calculated in the electronic case report form (eCRF) based
on height and body weight at screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30
milliliters per minute per 1.73 square metre (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
a fundus examination performed within 90 days before screening or in the period
between screening and randomisation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/01/2026
Actual
Sample size
Target
2700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Clinical Research Facility, Charles Perkins Centre - Camperdown
Recruitment hospital [2] 0 0
Holdsworth House Clinical Research - Darlinghurst
Recruitment hospital [3] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [4] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [5] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [6] 0 0
Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
Recruitment hospital [7] 0 0
St Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [8] 0 0
Baker IDI Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [4] 0 0
2291 - Merewether
Recruitment postcode(s) [5] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [6] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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Plzen 3
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Praha 1
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Czechia
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Praha 4
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Denmark
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Aarhus N
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Herlev
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Hillerød
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Hvidovre
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Odense C
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Finland
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Tampere
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Turku
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Berlin
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Daaden
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Dortmund
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Dresden
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Elsterwerda
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Germany
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Essen
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Gelnhausen
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Hamburg
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Lingen
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Ludwigshafen
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Lübeck
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München
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study will look at how well CagriSema helps people lower their blood sugar and body
weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and
cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide,
when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any
active ingredient. The study will be done in participants who have type 2 diabetes.
Participants will take the study medicine together with the current diabetes medicine
(metformin with or without an SGLT2 inhibitor).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06065540
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
clinicaltrials@novonordisk.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06065540