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Not yet recruitingPhase 2

A Study of HRS-4729 Injection in Participants With Type 2 Diabetes

A Phase II, Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of HRS-4729 Injection in Participants With Type 2 Diabetes

Assets

HRS-4729 / KAI-4729 / Mazdutide

Listed sites

2

Recruiting sites

-

Estimated enrollment

240

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 7.5-10.5%

Primary endpoint

•HbA1c

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07843862
Org study IDHRS-4729-203

Timeline

Milestones

Study first posted2026-09-28actual
Last update posted2026-09-28actual
Study start2026-10estimated (month precision)
Primary completion2027-04estimated (month precision)
Study completion2027-07estimated (month precision)

Assets

Investigational agents

HRS-4729 / KAI-4729Mazdutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Have Type 2 Diabetes

2. Treated with diet and exercise alone or with a stable dose of metformin

3. Have an HbA1c value at screening of ≥7.5% and ≤10.5%

Exclusion criteria

1. Have uncontrolled hypertension

2. Have Type 1 Diabetes, or specific types of diabetes

3. History of acute diabetic complications or severe hypoglycemic events

4. History of severe chronic diabetic complications, or non-proliferative diabetic retinopathy requiring treatment

5. History of any condition affecting gastric emptying, long-term use of medications directly affecting gastrointestinal motility, severe gastrointestinal disease, or prior gastrointestinal surgery

6. History or known history of acute or chronic pancreatitis, or pancreatic injury

7. History or known history of acute cholecystitis, or symptomatic/treatment-requiring gallbladder disease

8. Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2)

Endpoints (5)

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
3
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 28

percent change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Change From Baseline in HbA1c

Time frame:Baseline, Week 28

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7.0%, ≤6.5%, and <5.7%

Time frame:Baseline, Week 28

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose

Time frame:Baseline, Week 28

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

TEAEs

Time frame:Baseline, Week 32

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.