Type 2 DiabetesPhase 2NCT07843862
A Study of HRS-4729 Injection in Participants With Type 2 Diabetes
A Phase 2 study testing HRS-4729 Injection and Mazdutide in people with Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
The main purpose of this study is to evaluate the efficacy and safety of HRS-4729 Injection in participants with type 2 diabetes who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HRS-4729 Injection and Mazdutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2026to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have Type 2 Diabetes
- Treated with diet and exercise alone or with a stable dose of metformin
- Have an HbA1c value at screening of ≥7.5% and ≤10.5%
Who cannot join
- Have uncontrolled hypertension
- Have Type 1 Diabetes, or specific types of diabetes
- History of acute diabetic complications or severe hypoglycemic events
- History of severe chronic diabetic complications, or non-proliferative diabetic retinopathy requiring treatment
- History of any condition affecting gastric emptying, long-term use of medications directly affecting gastrointestinal motility, severe gastrointestinal disease, or prior gastrointestinal surgery
- History or known history of acute or chronic pancreatitis, or pancreatic injury
- History or known history of acute cholecystitis, or symptomatic/treatment-requiring gallbladder disease
- Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Tianjin Medical University Chu Hsien-I Memorial Hospital
Tianjin, Tianjin Municipality, 300134
Liming Chen
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Yan Yang
About this study
Official title: 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
The main purpose of this study is to evaluate the efficacy and safety of HRS-4729 Injection in participants with type 2 diabetes who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin.
- Conditions
- Type 2 Diabetes
- Being tested
- HRS-4729 Injection, Mazdutide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4729 InjectionDrug
HRS-4729 Injection
MazdutideDrug
Mazdutide
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: HRS-4729 Injection |
| Treatment group B | Experimental | Not described Receives: Drug: HRS-4729 Injection |
| Treatment group C | Experimental | Not described Receives: Drug: HRS-4729 Injection |
| Treatment group D | Experimental | Not described Receives: Drug: HRS-4729 Injection |
| Mazdutide | Active comparator | Not described Receives: Drug: Mazdutide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c
Measured: Baseline, Week 28
Secondary outcomes (4)
Percentage of Participants Reaching HbA1c <7.0%, ≤6.5%, and <5.7%
Measured: Baseline, Week 28
Percent Change From Baseline in Body Weight
Measured: Baseline, Week 28
Change From Baseline in Fasting Plasma Glucose
Measured: Baseline, Week 28
TEAEs
Measured: Baseline, Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Clinical Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843862
- Sponsor's protocol ID
- HRS-4729-203
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07843862
- Acronym / sponsor ID
- HRS-4729-203
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the efficacy and safety of HRS-4729 Injection in participants with type 2 diabetes who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Clinical Study
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRS-4729 Injection |
| Treatment group B | Experimental | Drug: HRS-4729 Injection |
| Treatment group C | Experimental | Drug: HRS-4729 Injection |
| Treatment group D | Experimental | Drug: HRS-4729 Injection |
| Mazdutide | Active comparator | Drug: Mazdutide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have Type 2 Diabetes
- Treated with diet and exercise alone or with a stable dose of metformin
- Have an HbA1c value at screening of ≥7.5% and ≤10.5%
Key exclusion criteria (8 listed)
- Have uncontrolled hypertension
- Have Type 1 Diabetes, or specific types of diabetes
- History of acute diabetic complications or severe hypoglycemic events
- History of severe chronic diabetic complications, or non-proliferative diabetic retinopathy requiring treatment
- History of any condition affecting gastric emptying, long-term use of medications directly affecting gastrointestinal motility, severe gastrointestinal disease, or prior gastrointestinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-4729 InjectionHRS-4729 Injection | Drug | Treatment group A, Treatment group B, Treatment group C, Treatment group D |
| MazdutideMazdutide | Drug | Mazdutide |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change From Baseline in HbA1c
Time frame: Baseline, Week 28
4 secondary outcomes
Percentage of Participants Reaching HbA1c <7.0%, ≤6.5%, and <5.7%
Time frame: Baseline, Week 28
Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 28
Change From Baseline in Fasting Plasma Glucose
Time frame: Baseline, Week 28
TEAEs
Time frame: Baseline, Week 32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-4729 Injection and Mazdutide in people with Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengshan Ni, M.D. (+86 0518-81220121, mengshan.ni.mn1@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in HbA1c (time frame: Baseline, Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.