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

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

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: HRS-7535
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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); Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: HRS-7535 tablet compared with placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Subjects will receive HRS-7535 administered orally | Drug: HRS-7535<br>* HRS-7535<br>|
| Experimental: Group B<br>Subjects will receive HRS-7535 administered orally | Drug: HRS-7535<br>* HRS-7535<br>|
| Experimental: Group C<br>Subjects will receive escalated dose of HRS-7535 administered orally | Drug: HRS-7535<br>* HRS-7535<br>|
| Experimental: Group D<br>Subjects will receive escalated HRS-7535 administered orally | Drug: HRS-7535<br>* HRS-7535<br>|
| Placebo Comparator: Group E<br>Subjects will receive Placebo administered orally | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in HbA1c at Week 16 |  | at Week 16] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change From Baseline in 7-point SMBG at Week 16 |  | at Week 16 | 
| Proportion of subjects receiving glycemic rescue medicine at Week 16 |  | at Week 16 | 
| A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[ |  | at Week 18 |