NCT04595370

Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease

A Phase 2b, Randomised, Double-Blind, Active Controlled, Multi Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients With Heart Failure and Chronic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 21 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone and to assess the dose-response relationship, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF \[below 60%\]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR \[between ≥ 20 and ≤ 60 mL/min/1.73 m\^2, with at least 20% of participants with eGFR ≥ 20 to \<30 mL/min/1.73\^2 and a maximum of 35% of participants with eGFR ≥ 45 mL/min/1.73 m\^2\]).

Detailed description

After screening, eligible participants will undergo a run-in period where all participants receive dapagliflozin for up to 7 weeks depending on pre-study use of SGLT2i or not. At the end of the run-in period, eligible participants will be randomly assigned with a 1:1:1:1 ratio to receive once daily administration of one of the following 4 study treatments group for 12 weeks. To ensure blinding, the study treatment will be administered in the form of 3 oral capsules of AZD9977 or placebo and 1 oral tablet or dapagliflozin. 1. AZD9977 Dose A + dapagliflozin 10 mg 2. AZD9977 Dose B + dapagliflozin 10 mg 3. AZD9977 Dose C + dapagliflozin 10 mg 4. Dapagliflozin 10 mg Participants will be randomized to one of the above treatment group, according to type 2 diabetes mellitus \[T2DM (yes/no)\] and eGFR (≥ 20 to \<30 mL/min/1.73\^2; or ≥ 30 to \< 45 mL/min/1.73\^2; or ≥45 mL/min/1.73\^2). The total duration of participation will be approximately 22 to 24weeks.

Conditions

• Heart Failure
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	AZD9977	Participants will receive AZD9977 as per the arms they are randomized.
DRUG	Dapagliflozin	Participants will receive dapagliflozin as per the arms they are randomized.

Timeline

• Start date: 2021-01-26
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2020-10-20
• Last updated: 2024-11-19
• Results posted: 2024-11-19

Locations

156 sites across 22 countries: United States, Belgium, Bulgaria, Canada, Czechia, Denmark, Germany, Hungary, India, Italy, Japan, Lithuania, Poland, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study