Recruiting NCT07564414

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

Phase III Interventional Obesity Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Cagrisema, Semaglutide.
Who it may be relevant to: Registry conditions: Obesity, Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Clinical Study to Compare Efficacy and Safety of Two Different Doses of CagriSema and Semaglutide in Participants With Obesity With or Without Type 2 Diabetes

Overview

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

Interventions

Drug Cagrisema
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Drug Semaglutide
Semaglutide will be administered subcutaneously.

Primary outcome measures

Relative change in body weight [Time frame: From randomisation (week 0) to end of treatment (week 72)]

Secondary outcome measures (12)

Relative change in body weight [Time frame: From randomisation (week 0) to end of treatment (week 72)]
Change in Body Mass Index (BMI) [Time frame: From randomisation (week 0) to end of treatment (week 72)]
Number of participants who achieve greater than or equal to (≥) 30% weight reduction [Time frame: From randomisation (week 0) to end of treatment (week 72)]
Number of participants who achieve ≥25% weight reduction [Time frame: From randomisation (week 0) to end of treatment (week 72)]
Number of participants who achieve greater ≥ 20% weight reduction [Time frame: From randomisation (week 0) to end of treatment (week 72)]
Change in waist circumference [Time frame: From randomisation (week 0) to end of treatment (week 72)]
Mean change in body weight [Time frame: From randomisation (week 0) to end of treatment (week 72)]
Number of participants who achieve a BMI less than (<) 30 kg/m^2 [Time frame: From randomisation (week 0) to end of treatment (week 72)]
Number of participants who achieve BMI <27 kg/m^2 [Time frame: end of treatment (week 72)]
Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2 [Time frame: At end of treatment (week 72)]
Number of participants who achieve a waist-to-height ratio < 0.53 [Time frame: At end of treatment (week 72)]
Ratio to baseline : Total cholesterol [Time frame: From baseline (week 0) to end of treatment (week 72)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment