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UnknownPhase 2

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

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 19-40HbA1c 7.5-11%

Primary endpoint

HbA1c

Identifiers

Registered as

NCT IDNCT05759897
Org study IDHRS-7535-201

Timeline

Milestones

Study start2023-02-28estimated
Study first posted2023-03-08actual
Last update posted2023-03-08actual
Primary completion2023-12-21estimated
Study completion2024-01-04estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
4
Weight & body composition
2
Other (unclassified)
2
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change From Baseline in body weight at Week 16

Time frame:at Week 16

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in waist circumference at Week 16

Time frame:at Week 16

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Mean Change From Baseline in HbA1c at Week 16

Time frame:at Week 16]

change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16

Time frame:at Week 16

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in fasting plasma glucose (FPG) at Week 16

Time frame:at Week 16

change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects receiving glycemic rescue medicine at Week 16

Time frame:at Week 16

threshold achievement, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[

Time frame:at Week 18

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change From Baseline in Mixed meal test at Week 16

Time frame:at Week 16

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.