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Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes

NCT ID: NCT06403761

Last Updated: 2025-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-06

Study Completion Date

2026-02-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CagriSema

Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks.

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

Participants will receive once-weekly semaglutide subcutaneously.

Cagrilintide

Intervention Type DRUG

Participants will receive once-weekly cagrilintide subcutaneously.

Placebo semaglutide

Intervention Type DRUG

Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

Placebo cagrilintide

Intervention Type DRUG

Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.

Semaglutide

Participants will receive once-weekly s.c injections of semaglutide at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks.

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

Participants will receive once-weekly semaglutide subcutaneously.

Placebo semaglutide

Intervention Type DRUG

Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

Cagrilintide

Participants will receive once-weekly s.c injections of cagrilintide at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks.

Group Type EXPERIMENTAL

Cagrilintide

Intervention Type DRUG

Participants will receive once-weekly cagrilintide subcutaneously.

Placebo cagrilintide

Intervention Type DRUG

Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.

Placebo

Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 28 weeks.

Group Type PLACEBO_COMPARATOR

Placebo semaglutide

Intervention Type DRUG

Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

Placebo cagrilintide

Intervention Type DRUG

Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.

Interventions

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Semaglutide

Participants will receive once-weekly semaglutide subcutaneously.

Intervention Type DRUG

Cagrilintide

Participants will receive once-weekly cagrilintide subcutaneously.

Intervention Type DRUG

Placebo semaglutide

Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

Intervention Type DRUG

Placebo cagrilintide

Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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U1111-1300-1930

Identifier Type: OTHER

Identifier Source: secondary_id

2023-509483-20

Identifier Type: OTHER

Identifier Source: secondary_id

NN9388-7782

Identifier Type: -

Identifier Source: org_study_id

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