NCT04727580

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2022

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

January 21, 2021

Last Update Submit

November 21, 2024

Conditions

Impaired Glucose Tolerance

Keywords

Impaired Glucose ToleranceDPP-4 inhibitorPrediabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (3)

HSK7653 10 mg

EXPERIMENTAL
Drug: HSK7653 10mg Q2W

HSK7653 25 mg

EXPERIMENTAL
Drug: HSK7653 25mg Q2W

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

HSK7653 10mg Q2WDRUG

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

HSK7653 10 mg
HSK7653 25mg Q2WDRUG

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

HSK7653 25 mg
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency General Hospital

Beijing, Beijing Municipality, 100028, China

Location

MeSH Terms

Conditions

Glucose IntolerancePrediabetic State

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 27, 2021

Study Start

March 29, 2021

Primary Completion

June 12, 2022

Study Completion

June 29, 2022

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)