Research study to look at how well semaglutide works in people living with heart failure, obesity and type 2 diabetes.

Phase 3

Completed

• Conditions: Diseases of the circulatory system,

• Registration Number: CTRI/2021/11/038164
• Lead Sponsor: Novo Nordisk AS

Brief Summary

This is a 52-week, randomised, placebo-controlled, double-blinded, multi-centre clinical trial comparing semaglutide s.c. 2.4 mg with placebo in subjects with obesity-related HFpEF and T2D.

Eligible subjects will be randomised in a 1:1 manner to receive either semaglutide s.c. 2.4 mg or placebo once-weekly as add-on to standard of care.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-24
• Last Update Posted: 2024-07-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

• Male or female, age above or equal to 18 years at the time of signing informed consent.
• Body mass index (BMI) ≥ 30.0 kg/m2 New York Heart Association (NYHA) Class II-IV Left ventricular ejection fraction (LVEF) ≥ 45% at screening Diagnosed with T2D ≥ 90 days prior to the day of screening HbA1c of ≤ 10.0% as measured at the screening visit.

Exclusion Criteria

• A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
• Verified by a fundus examination performed within 90 days prior to 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- Change in KCCQ clinical summary	1) Time frame-From baseline (week 0) to end of | treatment (week 52) | Unit- Score (no unit, range; 0-100) | 2) Time frame: From baseline (week 0) to end of | treatment (week 52) | Unit: %
score	1) Time frame-From baseline (week 0) to end of | treatment (week 52) | Unit- Score (no unit, range; 0-100) | 2) Time frame: From baseline (week 0) to end of | treatment (week 52) | Unit: %
2- Change in body weight	1) Time frame-From baseline (week 0) to end of | treatment (week 52) | Unit- Score (no unit, range; 0-100) | 2) Time frame: From baseline (week 0) to end of | treatment (week 52) | Unit: %
The 6MWT must be performed in accordance with the manual provided by Novo Nordisk	1) Time frame-From baseline (week 0) to end of | treatment (week 52) | Unit- Score (no unit, range; 0-100) | 2) Time frame: From baseline (week 0) to end of | treatment (week 52) | Unit: %

Secondary Outcome Measures

Name	Time	Method
Change in C-Reactive Protein	From baseline (week -2) to end of treatment (week 52)
Change in 6-minute walking distance	From baseline (week 0) to end of

Trial Locations

Locations (9)

Apollo Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Govind Ballabh Pant Institute of Postgraduate Medical Education and Research; 🇮🇳 Delhi, DELHI, India

King George’s Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Lisie Hospital; 🇮🇳 Ernakulam, KERALA, India

Max Super Speciality Hospital; 🇮🇳 Delhi, DELHI, India

S. P. Medical College & P.B.M. Hospital; 🇮🇳 Bikaner, RAJASTHAN, India

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

Vardhaman Mahavir Medical College & Safdarjung Hospital; 🇮🇳 Delhi, DELHI, India

Vijan Cardiac & Critical Care Centre; 🇮🇳 Nashik, MAHARASHTRA, India

Apollo Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr Abraham Oomman

Principal investigator

9841174578

drabrahamoomman@gmail.com