HSK7653 in Chinese Patients with Impaired Glucose Tolerance

Haisco Pharmaceutical Group

Status and phase: Completed; Phase 2

Conditions: Impaired Glucose Tolerance

Treatments: Drug: Placebo; Drug: HSK7653 10mg Q2W; Drug: HSK7653 25mg Q2W

Study type: Interventional

Funder types: Industry

Identifiers

NCT04727580

HSK7653-202

Details and patient eligibility

About

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

Enrollment: 99 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 3 patient groups, including a placebo group

HSK7653 10 mg

Experimental group

Treatment:

Drug: HSK7653 10mg Q2W

HSK7653 25 mg

Experimental group

Treatment:

Drug: HSK7653 25mg Q2W

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo