NCT05759897

Brief Summary

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_2 type-2-diabetes

Status
unknown

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

February 9, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

February 9, 2023

Last Update Submit

February 26, 2023

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in HbA1c at Week 16

    at Week 16]

Secondary Outcomes (8)

  • Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16

    at Week 16

  • Change From Baseline in fasting plasma glucose (FPG) at Week 16

    at Week 16

  • Change From Baseline in Mixed meal test at Week 16

    at Week 16

  • Change From Baseline in body weight at Week 16

    at Week 16

  • Change From Baseline in waist circumference at Week 16

    at Week 16

  • +3 more secondary outcomes

Study Arms (5)

Group A

EXPERIMENTAL

Subjects will receive HRS-7535 administered orally

Drug: HRS-7535

Group B

EXPERIMENTAL

Subjects will receive HRS-7535 administered orally

Drug: HRS-7535

Group C

EXPERIMENTAL

Subjects will receive escalated dose of HRS-7535 administered orally

Drug: HRS-7535

Group D

EXPERIMENTAL

Subjects will receive escalated HRS-7535 administered orally

Drug: HRS-7535

Group E

PLACEBO COMPARATOR

Subjects will receive Placebo administered orally

Drug: Placebo

Interventions

HRS-7535DRUG

HRS-7535

Group AGroup BGroup CGroup D
PlaceboDRUG

Placebo

Group E

Eligibility Criteria

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

You may qualify if:

  • Male or female, 18-75 age years, both inclusive;
  • Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
  • HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
  • Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
  • Body weight of at least 50 kg; and Body Mass Index (BMI) within the range of 19 to 40 kg/m2 (inclusive);

You may not qualify if:

  • Known or suspected allergy to the investigational drug or its components or excipients.
  • Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
  • Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
  • Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
  • History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study.
  • Discontinuation of previous glucagon-like peptide-1 receptor agonist therapy due to safety/tolerability reasons or lack of efficacy reasons.
  • Previous history of significant gastrointestinal disease (e.g. gastroesophageal reflux, gastric outlet obstruction, inflammatory bowel disease, active ulcers, etc.), or previous gastrointestinal surgery (except gastrointestinal polypectomy and appendectomy).
  • Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Yimei Xu

CONTACT

0518-82342973yimei.xu@hengrui.com

Shujin Cheng

CONTACT

0518-82342973shujin.cheng@hengrui.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: HRS-7535 tablet compared with placebo
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

March 8, 2023

Study Start

February 28, 2023

Primary Completion

December 21, 2023

Study Completion

January 4, 2024

Last Updated

March 8, 2023

Record last verified: 2023-02