Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure

What Was Tested

This registered phase 2, phase 3 trial tested Semaglutide for fat loss, obesity & body recomposition.

It had two arms (groups): Semaglutide intervention group (experimental) and Calorie-restricted diet intervention group (active comparator).

In short, the weight loss program in the calorie-restricted diet group consists of 3 phases after randomisation (week 0). An initial weight loss phase of 8 weeks with 800 calories/day, a food re-introduction phase for 8 weeks and a weight loss maintenance phase for the rest of the period of total 52 weeks.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Background: The prevalence of overweight and obesity has reached pandemic proportions.

Overweight and obesity are common in patients with CV disease; however, cardiologists face several challenges in managing body weight in this population.

Subjects will be randomised in a 1:1 ratio to receive either low-calorie replacement diet or semaglutide.The subjects wil be followed for 52 weeks during the intervention period.

The patients will be examined at 16 weeks (where the weight loss is anticipated to be approximately equal in the two groups) and after 52 weeks.

Who Took Part

100 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, age ≥ 18 years at the time of signing informed consent. Body mass index (BMI) ≥ 30 kg/m2. Cardiac magnetic resonance. On stable optimal medical heart failure therapy for at least 4 weeks.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: planned coronary, carotid or peripheral artery revascularisation known on the day of screening; transient heart failure related to reversible mechanisms like tachycardia, sepsis, etc; type 1 diabetes.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

In this single-blind Semaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2024-04-30 with completion listed for 2027-12-30.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Peak oxygen uptake (time frame: The patients will be examined after 0, 16 and 52 weeks).

It also tracked 4 secondary outcomes, for example The Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS), 6-min walk distance (6MWD), End-systolic volume of the left ventricle assessed by Cardiac MRI and N-terminal pro-B-type natriuretic peptide (NT-proBNP) and C-reactive protein (CRP) change.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Semaglutide in 100 people with fat loss, obesity & body recomposition.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.