HSK7653 in Chinese Patients with Impaired Glucose Tolerance

NCT ID: NCT04727580

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2022-06-29

Brief Summary

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

Conditions

Impaired Glucose Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HSK7653 10 mg

Group Type: EXPERIMENTAL

HSK7653 10mg Q2W

Intervention Type: DRUG

HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12

HSK7653 25 mg

Group Type: EXPERIMENTAL

HSK7653 25mg Q2W

Intervention Type: DRUG

HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12

Interventions

HSK7653 10mg Q2W

HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12

Intervention Type: DRUG

HSK7653 25mg Q2W

HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12

Intervention Type: DRUG

Placebo

Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Emergency General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HSK7653-202

Identifier Type: -

Identifier Source: org_study_id