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

Type 2 Diabetes Clinical Trial

Official title:

A 16-week Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05759897
• Other study ID #: HRS-7535-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 28, 2023
• Est. completion date: January 4, 2024

Study information

• Verified date: February 2023
• Source: Shandong Suncadia Medicine Co., Ltd.
• Contact: Yimei Xu
• Phone: 0518-82342973
• Email: yimei.xu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: January 4, 2024
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• HRS-7535
HRS-7535
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Suncadia Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in HbA1c at Week 16		at Week 16]
Secondary	Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16		at Week 16
Secondary	Change From Baseline in fasting plasma glucose (FPG) at Week 16		at Week 16
Secondary	Change From Baseline in Mixed meal test at Week 16		at Week 16
Secondary	Change From Baseline in body weight at Week 16		at Week 16
Secondary	Change From Baseline in waist circumference at Week 16		at Week 16
Secondary	Change From Baseline in 7-point SMBG at Week 16		at Week 16
Secondary	Proportion of subjects receiving glycemic rescue medicine at Week 16		at Week 16
Secondary	A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[		at Week 18