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

Shandong Suncadia Medicine

Status and phase: Not yet enrolling; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: HRS-7535

Study type: Interventional

Funder types: Industry

Identifiers

NCT05759897

HRS-7535-201

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 5 patient groups, including a placebo group

Group A

Experimental group

Description:

Subjects will receive HRS-7535 administered orally

Treatment:

Drug: HRS-7535

Group B

Experimental group

Description:

Subjects will receive HRS-7535 administered orally

Treatment:

Drug: HRS-7535

Group C

Experimental group

Description:

Subjects will receive escalated dose of HRS-7535 administered orally

Treatment:

Drug: HRS-7535

Group D

Experimental group

Description:

Subjects will receive escalated HRS-7535 administered orally

Treatment:

Drug: HRS-7535

Group E

Placebo Comparator group

Description:

Subjects will receive Placebo administered orally

Treatment:

Drug: Placebo