Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Dose gradually escalated from 0.25 mg until target dose. The study will last for approximately 59 weeks.
• Placebo (semaglutide) — DRUG
  Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. The study will last for approximately 59 weeks.

Study Details

This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity. The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.

Key Dates

Start date

Mar 16, 2021

Status verified

Nov 2025

Primary completion

Apr 18, 2023

Completion

Apr 18, 2023

Study Design

Enrollment

529 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide
  All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
• Placebo Comparator: Placebo (semaglutide)
  All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.

Primary Outcome Measure

Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]

Locations (50)

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