Clinical trial NCT05759897: A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HRS-7535 tablet compared with placebo
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: Mean Change From Baseline in HbA1c at Week 16
timeFrame: at Week 16]
Secondary outcomes:
measure: Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16
timeFrame: at Week 16
measure: Change From Baseline in fasting plasma glucose (FPG) at Week 16
timeFrame: at Week 16
measure: Change From Baseline in Mixed meal test at Week 16
timeFrame: at Week 16
measure: Change From Baseline in body weight at Week 16
timeFrame: at Week 16
measure: Change From Baseline in waist circumference at Week 16
timeFrame: at Week 16
measure: Change From Baseline in 7-point SMBG at Week 16
timeFrame: at Week 16
measure: Proportion of subjects receiving glycemic rescue medicine at Week 16
timeFrame: at Week 16
measure: A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[
timeFrame: at Week 18
Other outcomes:
Locations:
Study officials:
References: