Effect of Semaglutide 2.4 mg once-weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction, and type 2 diabetes

JRCT ID: jRCT2061210014

Registered date:17/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type2 diabetes and obesity-related heart failure with preserved ejection fraction
• Date of first enrollment: 15/06/2021
• Target sample size: 610
• Countries of recruitment: Argentina,Japan,Austria,Japan,Canada,Japan,Germany,Japan,Hungary,Japan,India,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): semaglutide subcutaneous (s.c.) 2.4 mg once-weekly added to standard of care

Outcome(s)

Primary Outcome

Multiple primary endpoints
-Change in KCCQ clinical summary
-score (no unit, range; 0-100) From baseline (week 0) to end of treatment (week 52)
-Change in body weight (%) From baseline (week 0) to end of treatment (week 52)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Male or female, age above or equal to 20 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

Exclude 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.

Related Information

• Primary Sponsor: Kinoshita Kazunori
• Secondary ID(s): NCT04916470