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 3RecruitingNCT07564414

Novo Nordisk A/S2,500 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

2,500

Conditions

Obesity Type 2 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (303)

Uni of Alabama at Birmingham

Birmingham, Alabama, United States

ACTIVE_NOT_RECRUITING

Cahaba Research

Pelham, Alabama, United States

ACTIVE_NOT_RECRUITING

Elligo Health Research Inc

Gilbert, Arizona, United States

ACTIVE_NOT_RECRUITING

Velocity Clinical Research-Phoenix

Phoenix, Arizona, United States

ACTIVE_NOT_RECRUITING

Outcomes

Primary Outcomes

Relative change in body weight

Measured as percentage (%).

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

Secondary Outcomes

Relative change in body weight

Measured as %.

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

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)

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)

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)

Number of participants who achieve greater ≥ 20% weight reduction

Measured as count of participants.

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

Change in waist circumference

Measured in centimetre (cm).

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

Mean change in body weight

Measured in kilograms (kg).

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

Measured as count of participants.

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

Number of participants who achieve BMI <27 kg/m^2

Measured as count of participants.

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

Measured as count of participants.

Time frame: At end of treatment (week 72)

Number of participants who achieve a waist-to-height ratio < 0.53

Measured as count of participants.

Time frame: At end of treatment (week 72)

Ratio to baseline : Total cholesterol

Measured in terms of ratio.

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

Ratio to baseline : High density lipoprotein (HDL) cholesterol

Measured in terms of ratio.

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

Ratio to baseline : Low density lipoprotein (LDL) cholesterol

Measured in terms of ratio.

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

Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol

Measured in terms of ratio.

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

Ratio to baseline : Triglycerides

Measured in terms of ratio.

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

Ratio to baseline: Free fatty acids

Measured in terms of ratio.

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

Ratio to baseline : Non-HDL cholesterol

Measured in terms of ratio.

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

Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function

Measured as score on a scale. The SF-36v2 acute measures health-related quality of life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.

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

Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function

Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.

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

Change in glycated haemoglobin (HbA1c)

Measured in %-points.

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

Number of participants who achieve HbA1c <6.5%

Measured as count of participants.

Time frame: At end of treatment (week 72)

Number of participants who achieve normal HbA1c <5.7%

Measured as count of participants.

Time frame: At end of treatment (week 72)

Number of treatment-emergent adverse events (TEAEs)

Measured in number of events.

Time frame: From randomisation (week 0) to end of study (week 80)

Number of treatment-emergent serious adverse events (TESAEs)

Measured in number of events.

Time frame: From randomisation (week 0) to end of study (week 80)

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

Overview

Conditions

Interventions

Eligibility

Locations (303)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts