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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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 83 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last for about 83 weeks"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe two doses of CagriSema are and how well they help adults with obesity lose weight, with or without type 2 diabetes. It compares CagriSema, a new study medicine, with one dose of semaglutide, a medicine doctors can already prescribe. Treatment is chosen by chance, and the study lasts about 83 weeks.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older when signing the consent form.
  • People of all gender identities may join.
  • Body mass index (BMI), a measure of weight compared with height, of 35 or higher.
  • If you do not have type 2 diabetes: no history of it and an HbA1c below 6.5%. HbA1c is a blood test that shows your average blood sugar.
  • If you have type 2 diabetes: an HbA1c below 10%.
  • If you have no history of diabetes but your HbA1c is 6.5% or higher during screening, a study doctor or your healthcare provider must confirm type 2 diabetes before treatment is assigned.

Who can't join

  • Your weight changed by more than 5% in the 90 days before screening, based on what you report.
  • You used a GLP-1 or amylin medicine in the 6 months before screening. These medicines act like hormones that help control blood sugar or appetite.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (99)

AL

AR

AZ

CA

CO

FL

GA

IA

ID

IL

KS

KY

MD

MI

MN

MO

MS

NC

ND

NY

OH

OK

PA

RI

SC

TN

TX

UT

VA

WI