Health Trials

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

ConditionsObesityType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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/m².

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cagrisema

    Drug

    Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.

  • Semaglutide

    Drug

    Semaglutide will be administered subcutaneously.

Treatment groups

2,500 Participants
are divided into 3 treatment groups
Group A: Cagrisema - dose level 1Experimental treatment 1 intervention
Group B: Cagrisema - dose level 2Active comparator 1 intervention
Group C: SemaglutideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Relative change in body weight

Measured as percentage (%).

Time frame
From randomisation (week 0) to end of treatment (week 72)

Secondary outcomes

1

Relative change in body weight

Measured as %.

Time frame
From randomisation (week 0) to end of treatment (week 72)
2

Change in Body Mass Index (BMI)

Measured as kilograms per square metre (kg/m\^2).

Time frame
From randomisation (week 0) to end of treatment (week 72)
3

Number of participants who achieve greater than or equal to (≥) 30% weight reduction

Measured as count of participants.

Time frame
From randomisation (week 0) to end of treatment (week 72)
4

Number of participants who achieve ≥25% weight reduction

Measured as count of participants.

Time frame
From randomisation (week 0) to end of treatment (week 72)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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