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A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus
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
Lead sponsor
Asset
KAI-7535 / HRS-7535
Oral · GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
180
estimated
Study population
Type 2 diabetes
Key I/E criteria
•BMI 19-40•HbA1c 7.5-11%
Primary endpoint
•HbA1c
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChange From Baseline in body weight at Week 16
Time frame:at Week 16
change from baseline, improvement
Change From Baseline in waist circumference at Week 16
Time frame:at Week 16
change from baseline, improvement
Glycemic / diabetes
4 endpointsMean Change From Baseline in HbA1c at Week 16
Time frame:at Week 16]
change from baseline, improvement
Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16
Time frame:at Week 16
threshold achievement, improvement
Change From Baseline in fasting plasma glucose (FPG) at Week 16
Time frame:at Week 16
change from baseline, improvement
Proportion of subjects receiving glycemic rescue medicine at Week 16
Time frame:at Week 16
threshold achievement, improvement
Safety / tolerability / PK
1 endpointA summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[
Time frame:at Week 18
descriptive
Other (unclassified)
2 endpointsChange From Baseline in Mixed meal test at Week 16
Time frame:at Week 16
change from baseline, improvement
Change From Baseline in 7-point SMBG at Week 16
Time frame:at Week 16
change from baseline, improvement
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID42234428via clinicaltrials gov reference derived
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.