A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus
Type 2 Diabetes
About this trial
This is an interventional other trial for Type 2 Diabetes
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Group A
Group B
Group C
Group D
Group E
Subjects will receive HRS-7535 administered orally
Subjects will receive HRS-7535 administered orally
Subjects will receive escalated dose of HRS-7535 administered orally
Subjects will receive escalated HRS-7535 administered orally
Subjects will receive Placebo administered orally