DRUG
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes
Status
Completed
Phase
Phase 1
Enrollment
158
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This study will look at how CagriSema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes (T2D). CagriSema is a new investigational medicine that combines two medicines called cagrilintide and semaglutide. Doctors may not yet prescribe CagriSema. Participants will either get CagriSema, semaglutide, cagrilintide, or a ''dummy'' medicine. Which treatment the participants will get is decided by chance. Participants will get the study medicine together with the current daily diabetes medicine metformin. Participants should not take other medicines for diabetes during the study. The study will last for about 42 weeks.
Interventions
Treatment arms and agents.
DRUG
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
DRUG
Placebo semaglutide
Participants will receive once-weekly placebo matched to semaglutide subcutaneously.
DRUG
Placebo cagrilintide
Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.
Timeline
From registration to results.
First posted
May 8, 2024
Study start
May 6, 2024
Primary completion
Dec 28, 2025
Study completion
Feb 2, 2026
Results posted
Not reported
Registry updated
Feb 27, 2026
Outcomes
What the study measures.
Primary outcomes
To compare the effect of CagriSema versus placebo: Change in M-value in hyperinsulinaemic euglycaemic clamp (HEC)
Time frame · Baseline to week 28
M-value from the HEC is calculated from glucose infusion rate (GIR) over the last 30 minutes of the clamp, corresponding to steady state. M-value is defined as: (GIR150-180 min normalised by body weight \[milligram per minute per kilogram {mg/min/kg}\]). Measured in mg/min/kg.
Secondary outcomes
To compare the effect of CagriSema versus semaglutide, Semaglutide versus placebo and Cagrilintide versus placebo: Change in M-value in HEC
Time frame · Baseline to week 28
M-value from the HEC is calculated from GIR over the last 30 minutes of the clamp, corresponding to steady state. M-value is defined as: (GIR150-180 min normalised by body weight \[mg/min/kg\]). Measured in mg/min/kg.
To compare the effect of CagriSema versus placebo, CagriSema versus semaglutide, Semaglutide versus placebo and Cagrilintide versus placebo: Change in M-value in HEC, normalised by lean body mass
Time frame · Baseline to week 28
M-value from the HEC is calculated from GIR over the last 30 minutes of the clamp, corresponding to steady state. M-value is defined as: (GIR150-180 min normalised by body weight \[mg/min/kg\]). Measured in mg/min/kg.
Change in first-phase incremental insulin secretion rate (ISR0-8min) in hyperglycaemic clamp (HGC)
Time frame · Baseline to week 28
Measured in picomoles per minute per square meter (pmol/min/m\^2).
Change in second-phase insulin secretion rate (ISR20-120min) in HGC
Time frame · Baseline to week 28
Measured in pmol/min/m\^2.
Change in total insulin secretion rate (ISR0-120min) in HGC
Time frame · Baseline to week 28
Measured in pmol/min/m\^2.
Change in insulin secretion rate at fixed glucose concentration (ISRg) in HGC
Time frame · Baseline to week 28
Measured in pmol/min/m\^2.
Change in total insulin response (total AUC0-120 min) in HGC
Time frame · Baseline to week 28
Measured in minute \* picomoles per liter (min\*pmol/L).
Change in insulin response to arginine (incremental insulin AUCarginine,0-10min) in HGC
Time frame · Baseline to week 28
Measured in min\*pmol/L.
Change in C-peptide response to arginine (incremental insulin AUCarginine,0-10min) in HGC
Time frame · Baseline to week 28
Measured in min\*nmol/L.
Change in clamp disposition index (cDI) calculated from HEC and HGC
Time frame · Baseline to week 28
cDI is defined as the product of the M-value derived from the hyperinsulinemic euglycemic clamp over the last 30 minutes and total insulin secretion (ISR AUC0-120min) derived from the insulin secretion rate based on C-peptide using the using the deconvolution technique divided by the total glucose AUC0-120min from the hyperglycemic clamp portion of the study. Measured in picomoles \* liter per square meter per square minute per kilogram (pmol\*L/m\^2/min\^2/kg).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Male or female. * Aged 18-75 years (both inclusive) at the time of signing informed consent. * Diagnosed with type 2 diabetes greater than or equal to (\>=) 180 days before screening. * Stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for 90 or more days before screening with or without one additional oral antidiabetic drug (OAD), except for the use of glucagon-like peptide-1 (GLP-1) receptor agonists, or sodium-glucose co-transporter-2 (SGLT-2) inhibitors in case of a high risk of cardiovascular disease (as judged by the investigator), or established cardiovascular disease, or chronic kidney disease (Glomerular Filtration Rate (eGFR) less than (\<) 60 milliliter per minute per 1.73 square meter \[ml/min/1.73 m\^2\]). * Glycated hemoglobin (HbA1c) at screening of 6.5-9.5 percent (48-80 millimoles per mole \[mmol/mol\]) (both inclusive) if on metformin only, or 6.0- 9.0 percent (42-75 mmol/mol) (both inclusive) if on metformin in combination with one other OAD. A minimum of 65% of randomised participants must have HbA1c \>= 7.0 % at screening. * Body Mass index (BMI) between 25.0 and 45.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. * 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. * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73 m\^2 at screening. * Treatment with any medication for the indication of T2D or weight management 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.
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Cagrilintide.
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Put the record in context.
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