HSK7653 in Chinese Patients With Impaired Glucose Tolerance

• Status: Recruiting
• Trial end date: 2022-06-28
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Criteria

Inclusion Criteria:

• Impaired glucose tolerance;

• BMI (Body Mass Index) in the range of ≥ 18.0 kg/m2 to ≤ 35.0 kg/m2 at screening;

Exclusion Criteria:

• History of diabetes mellitus;

• History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;

• Current uncontrolled hypertension, serious nephropathy prior to informed consent;

• Serious Heart Failure (class III-IV of the New York Heart Association functional classification), serious Arrhythmia, and Stroke within 6 months prior to informed consent;

• Serious gastrointestinal disease within 2 weeks prior to informed consent;

• Serious infection, trauma, and surgery within 3 months prior to informed consent;

• History of treatment with Glucagon-like peptide 1(GLP-1) analogues, Dipeptidyl-Peptidase 4(DPP-IV) inhibitor;

• Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent;

• Hemoglobin (HGB) < 10.0 g/dL(100 g/L);

• Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent;

• Active infectious diseases;

• Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent;

• Women who are nursing or pregnant, or subjects with birth plans;

• Other protocol-defined inclusion/exclusion criteria.