HSK7653 in Chinese Patients with Impaired Glucose Tolerance

Phase 2

Completed

• Conditions: Impaired Glucose Tolerance
• Interventions: Drug: HSK7653 10mg Q2W; Drug: HSK7653 25mg Q2W; Drug: Placebo

• Registration Number: NCT04727580
• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-27
• Study Start: 2021-03-29
• Primary Completion: 2022-06-12
• Study Completion: 2022-06-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HSK7653 10 mg	HSK7653 10mg Q2W	-
HSK7653 25 mg	HSK7653 25mg Q2W	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12	Baseline and Week 12	Plasma glucose AUC 0-3 hours for MTT was measured at Baseline (Week 0) and at Week 12. After fasting for ≥8 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 180 minutes. At Week 12, participants received study drug or placebo 50 minutes prior to consuming a standard meal.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) at Week 12	Baseline and Week 12
Change From Baseline in Fasting Insulin at Week 12	Baseline and Week 12
Change From Baseline in HOMA-β at Week 12	Baseline and Week 12
Change From Baseline in Fasting C-peptide at Week 12	Baseline and Week 12
Change From Baseline in Fasting Glucose at Week 12	Baseline and Week 12
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12	Baseline and Week 12
Change From Baseline in C-peptide AUC 0-3h for Meal Tolerance Test (MTT) at Week 12	Baseline and Week 12
Change From Baseline in HOMA-IS at Week 12	Baseline and Week 12
Incidence of Treatment-Emergent Adverse Events	Baseline and Week 12
Change From Baseline in Plasma Glucose Area Under the Curve 0 to 3 Hours (AUC 0-3 Hrs) for Oral Glucose Tolerance Test (OGTT) at Week 10	Baseline and Week 10

Trial Locations

Locations (1)

Emergency General Hospital; 🇨🇳 Beijing, Beijing, China