Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cagrisema - dose level 1
Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.
  • Drug: Cagrisema
    Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Active Comparator
Cagrisema - dose level 2
Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.
  • Drug: Cagrisema
    Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Active Comparator
Semaglutide
Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.
  • Drug: Semaglutide
    Semaglutide will be administered subcutaneously.

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.