A research study to see how well CagriSema helps people with type 2 diabetes and excess body weight lose weight

Phase 3

• Conditions: Health Condition 1: E669- Obesity, unspecifiedHealth Condition 2: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2023/04/051486
• Lead Sponsor: ovo Nordisk AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male or female

2.Age above or equal to 18 years at the time of signing informed consent

3. BMI greather than or equal to 27.0 kg per m2

4. Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening

5.Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, a-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label

6. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening

7. HbA1c below or equal to 10% (86 mmol/mol) as measured by the central laboratory at screening

Exclusion Criteria

1.Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness.

2.Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL per min per 1.73 m2 (below 45 mL per min per 1.73 m2 in participants treated with SGLT2i), as measured by the central laboratory at screening.

3.Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Relative change in body weight <br/ ><br>2.Achievement of greater than or equal to 5percent <br/ ><br>weight reductionTimepoint: 1.Time Frame: <br/ ><br>From baseline (week 0) to end of treatment <br/ ><br>(week 68) <br/ ><br>2.Time Frame: From baseline <br/ ><br>(week 0) to end of treatment (week 68)

Secondary Outcome Measures

Name	Time	Method
Achievement of more than or equal to 20 percent weight reductionTimepoint: Time Frame: From baseline (week 0) to end of treatment (week 68) Count of participant;Change in Glycated Haemoglobin (HbA1c)Timepoint: Time Frame: From baseline (week 0) to end of treatment (week 68) percentage-points;Change in Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function scoreTimepoint: Time Frame: From baseline (week 0) to end of treatment (week 68) ,Score points;Change in Short Form-36 Version 2.0 (SF-36v2) Physical Functioning scoreTimepoint: Time Frame: From baseline (week 0) to end of treatment (week 68),Score points;Change in Systolic Blood Pressure (SBP)Timepoint: Time Frame: From baseline (week 0) to end of treatment (week 68),Measured in mmHg;Change in waist circumferenceTimepoint: Time Frame: From baseline (week 0) to end of treatment (week 68),Measured in cm;Relative change in body weightTimepoint: Time Frame: From baseline (week 0) to week 20,Measured in percentage.