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

Phase 1

• Conditions: Heart failure with preserved ejection fractionDiabetes Mellitus, type 2; MedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-004170-22-ES
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-22
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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) at least 30.0 kg/m^2
- New York Heart Association (NYHA) Class II-IV
- Left ventricular ejection fraction (LVEF) at least 45% at screening
- Diagnosed with T2D at least 90 days prior to the day of screening
- HbA1c of maximum 10.0% as measured at the screening visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 305
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 305

Exclusion Criteria

- A self-reported change in body weight more than 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effects of semaglutide s.c. 2.4 mg once-weekly on physical function, symptoms and body weight compared with placebo, both added to standard of care, in subjects with obesity-related HFpEF and T2D.;Primary end point(s): 1. Change in KCCQ clinical summary score<br>2. Change in body weight;Secondary Objective: To investigate the effects of semaglutide s.c. 2.4 mg once-weekly on walking distance, biomarker of inflammation, disease specific aspects, social limitation, change in body composition, health-related quality of life, and glycaemic control and hypoglycaemia compared with placebo, both added to standard of care, in subjects with obesity-related HFpEF and T2D.;Timepoint(s) of evaluation of this end point: 1.-2. From baseline (week 0) to end of treatment (week 52)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in C-Reactive Protein<br>2. Change in 6-minute walking distance<br>3. Subject achieving 10% weight loss or more (Yes/No)<br>4. Subject achieving 15% weight loss or more (Yes/No)<br>5. Subject improving 5 points or more in KCCQ clinical summary score (Yes/No)<br>6. Subject improving 10 points or more in KCCQ clinical summary score (Yes/No)<br>7. Change in KCCQ overall summary score<br>8. Change in waist circumference<br>9. Change in systolic blood pressure<br>10. Change in HbA1c<br>11. Number of treatment emergent severe or clinically significant hypoglycaemia episodes;Timepoint(s) of evaluation of this end point: 1. and 9. From baseline (week -2) to end of treatment (week 52)<br>2.-8. and 10. From baseline (week 0) to end of treatment (week 52)<br>11. From baseline (week 0) to end of trial (week 57)