HSK7653 in Chinese Patients With Impaired Glucose Tolerance

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Clinical Trial to Study the Efficacy and Safety of HSK7653 in Chinese Patients With Impaired Glucose Tolerance

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

Study Overview

• Status: Recruiting
• Conditions: Impaired Glucose Tolerance
• Intervention / Treatment: Drug: HSK7653 10mg Q2W; Drug: HSK7653 25mg Q2W; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: fangqiong Li; Phone Number: +8602867258840; Email: lifangq@haisco.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100028
      • Recruiting
      • Emergency General Hospital
      • Contact: Hongmei Li; Phone Number: +8613911151692; Email: lihongmei64@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12
Experimental: HSK7653 10 mg	Drug: HSK7653 10mg Q2W; HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12
Experimental: HSK7653 25 mg	Drug: HSK7653 25mg Q2W; HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at 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.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) 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 Fasting Glucose at Week 12	Baseline and Week 12
Change From Baseline in Fasting Insulin 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 HOMA-IS at Week 12	Baseline and Week 12
Change From Baseline in HOMA-β 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 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
Incidence of Treatment-Emergent Adverse Events	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): June 21, 2022
• Study Completion (Anticipated): June 28, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 11, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Prediabetes; Impaired Glucose Tolerance; DPP-4 inhibitor
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: HSK7653-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No