A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

Novo Nordisk

Status and phase: Begins enrollment this month; Phase 3

Conditions: Obesity; Type 2 Diabetes

Treatments: Drug: Cagrisema; Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07564414

2025-522488-14 (Other Identifier)

U1111-1323-0372 (Other Identifier)

NN9838-7910

Details and patient eligibility

About

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Male or female (sex assigned at birth, inclusive of all gender identities).
• Age 18 years or above at the time of signing the informed consent.
• BMI≥ 35.0 kg/m^2.
• Participants without T2D: No history of T2D and HbA1c < 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c < 10% (< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.

Exclusion Criteria:

• A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records.
• Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,500 participants in 3 patient groups

Cagrisema - dose level 1

Experimental group

Description:

Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.

Treatment:

Drug: Cagrisema

Cagrisema - dose level 2

Active Comparator group

Description:

Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.

Treatment:

Drug: Cagrisema

Semaglutide

Active Comparator group

Description:

Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.

Treatment:

Drug: Semaglutide