Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Kidney Disease
  • Heart Failure
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants who meet the eligibility criteria will be randomized to one of the following treatment group: AZD9977 Dose A + dapagliflozin 10 mg AZD9977 Dose B + dapagliflozin 10 mg AZD9977 Dose C + dapagliflozin 10 mg AZD9977 Dose C Dapagliflozin 10 mg Placebo Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 130 years
Gender
Both males and females

Description

The study will be conducted in approximately 140 sites in about 12 countries. After screening, eligible participants will undergo a 3 to 4-week run-in period to ensure washout of prior medications. At the end of the run-in period, eligible participants will be randomly assigned with a 1:1:1:1:1:1 ra...

The study will be conducted in approximately 140 sites in about 12 countries. After screening, eligible participants will undergo a 3 to 4-week run-in period to ensure washout of prior medications. At the end of the run-in period, eligible participants will be randomly assigned with a 1:1:1:1:1:1 ratio to receive once daily administration of one of the following study treatments group for 12 weeks: AZD9977 Dose A + dapagliflozin 10 mg AZD9977 Dose B + dapagliflozin 10 mg AZD9977 Dose C + dapagliflozin 10 mg AZD9977 Dose C Dapagliflozin 10 mg Placebo Participants will be randomized to one of the above treatment group, according to T2DM (yes/no) and eGFR (<30 mL/min / ? 30 to ? 45 mL/min / >45 mL/min). The total duration of participation will be approximately 19 to 21 weeks.

Tracking Information

NCT #
NCT04595370
Collaborators
Not Provided
Investigators
Principal Investigator: John McMurray University of Glasgow, United Kingdom