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Clinical Trials List

Protocol NumberD6402C00001

NCT Number(ClinicalTrials.gov Identfier)NCT04595370

2021-05-18 - 2023-12-31

Phase II

Not yet recruiting5

Recruiting5

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

Trial Applicant

PAREXEL INTERNATIONAL CO., LTD.
Sponsor

AstraZeneca AB
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator 洪崇烈醫師 Division of Cardiovascular Diseases

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 翁國昌 Division of Cardiovascular Diseases

Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chern-En Chiang Division of Cardiovascular Diseases

Taipei Veterans General Hospital

Taiwan National PI

江晨恩

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsi-Hsien Chen 無

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator VIN-CENT Wu 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ming-Ju Wu 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Heng-Chih Pan 無

Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 鄭本忠無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Heart Failure

Objectives

To evaluate the effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on UACR To assess the dose-response relationship of dapagliflozin (10 mg) alone and 3 doses of AZD9977 (15, 50, or 150 mg) combined with dapagliflozin (10 mg) on UACR

Test Drug

AZD9977及Dapagliflozin

Active Ingredient

AZD9977
Dapagliflozin

Dosage Form

capsule
tablet

Dosage

15, 50,100
10

Endpoints

Percent change from baseline in UACR at the end of 12 weeks of study treatment
Percent change from baseline in UACR at the end of 12 weeks of study treatment

Inclution Criteria

1. Participant must be 21 years of age or older, at the time of signing the informed consent.
2. Documented diagnosis of stable symptomatic HF (NYHA class II-III) at screening (Visit 1a), and a medical history of typical symptoms and signs of HF in those who are currently receiving loop diuretic treatment.
3. Left ventricular ejection fraction < 60% documented by the most recent echocardiogram 2D or 3D or cardiac magnetic resonance imaging within the last 12 months prior to screening.
4. Patients should be treated for HF, hypertension, T2DM, or renal disease according to guidelines.
5. NT-proBNP ≥ 300 pg/mL for patients with sinus rhythm at screening; and NT proBNP ≥ 600 pg/mL for patients with atrial fibrillation/flutter at screening, using local laboratory sample.
6. eGFR ≥ 30 and ≤ 60 mL/min/1.73 m2 (by CKD-EPI formula based on local laboratory sample).

Exclusion Criteria

1 Primary glomerulopathy, vasculitic renal disease (including ANCA-associated vasculitis), prior dialysis or unstable rapidly progressing renal disease, autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis.
2 Patients with currently decompensated HF requiring hospitalisation for optimisation of HF treatment and are not on stable HF therapy at the time of enrolment.
3 HF due to cardiomyopathies that would primarily require specific other treatment such as cardiomyopathy due to amyloidosis or infiltrative diseases, primary hypertrophic cardiomyopathy, cardiomyopathy related to current toxic or infective conditions (ie,
ongoing chemotherapy, infective myocarditis, septic cardiomyopathy).
4 High output HF (eg, due to hyperthyroidism or Paget’s disease).
5 HF due to pericardial disease, congenital heart disease or clinically significant uncorrected primary cardiac valvular disease or planned cardiac valve repair/replacement.
6 Patients with uncontrolled diabetes mellitus (HbA1c > 10%).
7 Patients with T1DM.
8 Intermittent or persistent 2nd or 3rd degree atrioventricular block, sinus node dysfunction with clinically significant bradycardia or sinus pauses, not treated with a pacemaker.

The Estimated Number of Participants

Taiwan

30 participants
Global

540 participants