A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus

NCT ID: NCT05759897

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-01-04

Brief Summary

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

Conditions

Type 2 Diabetes

Study Design

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

Study Groups

Group A

Subjects will receive HRS-7535 administered orally

Group Type: EXPERIMENTAL

HRS-7535

Intervention Type: DRUG

HRS-7535

Group B

Subjects will receive HRS-7535 administered orally

Group Type: EXPERIMENTAL

HRS-7535

Intervention Type: DRUG

HRS-7535

Group C

Subjects will receive escalated dose of HRS-7535 administered orally

Group Type: EXPERIMENTAL

HRS-7535

Intervention Type: DRUG

HRS-7535

Group D

Subjects will receive escalated HRS-7535 administered orally

Group Type: EXPERIMENTAL

HRS-7535

Intervention Type: DRUG

HRS-7535

Group E

Subjects will receive Placebo administered orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

HRS-7535

HRS-7535

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female, 18-75 age years, both inclusive;

2. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;

3. HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;

4. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.

5. Body weight of at least 50 kg; and Body Mass Index (BMI) within the range of 19 to 40 kg/m2 (inclusive);

Exclusion Criteria

1. Known or suspected allergy to the investigational drug or its components or excipients.

2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.

3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.

4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;

5. 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.

6. Discontinuation of previous glucagon-like peptide-1 receptor agonist therapy due to safety/tolerability reasons or lack of efficacy reasons.

7. 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).

8. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

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

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yimei Xu

Role: CONTACT

yimei.xu@hengrui.com

0518-82342973

Shujin Cheng

Role: CONTACT

shujin.cheng@hengrui.com

0518-82342973

Other Identifiers

HRS-7535-201

Identifier Type: -

Identifier Source: org_study_id