Overweight or ObesityPhase 2NCT07690826
A Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Obesity
A Phase 2 study testing HRS-4729 Injection and HRS-4729 Injection; in people with Overweight or Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of once-weekly HRS-4729 injection in adults with obesity without diabetes. Approximately 252 participants will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- HRS-4729 Injection and HRS-4729 Injection;
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- Jul 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
- Able and willing to provide a written informed consent.
- Male or female adults aged 18 to 65 years.
- BMI: 28.0 to 40.0 kg/m2.
- Self-reported diet and exercise control for at least 3 months before screening, with body weight change of no more than 5 kg during the previous 3 months.
Who cannot join
- Endocrine disease or history that may have a significant effect on body weight;
- History of diabetes mellitus (gestational diabetes excepted);
- Malignancy of any organ system within the past 5 years, irrespective of evidence of local recurrence or metastasis, except for adequately treated localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, and prostate carcinoma in situ;
- Presence or suspicion of depression, anxiety disorder, bipolar disorder, suicidal ideation, schizophrenia, or other clinically significant psychiatric disorder, or a history of suicide attempt;
- Known or suspected excessive alcohol use, or a history of alcohol, drug, or substance abuse;
- Acute or chronic hepatitis, or a history of severe hepatic disease other than metabolic dysfunction-associated fatty liver disease;
Show all 15Show fewer
- Prior or planned organ or bone marrow transplantation during the study period;
- Any hematologic disorder that may interfere with the determination of HbA1c;
- An autoimmune disease for which systemic corticosteroid or immunosuppressive therapy is planned during the study period;
- Use of any medication or treatment likely to cause clinically significant weight gain or weight loss within 3 months prior to screening;
- Participation in any clinical trial of an investigational drug or medical device within 3 months prior to screening;
- Blood donation or blood loss ≥400 mL, or receipt of a blood transfusion, within 3 months prior to screening;
- Mental incapacity or language impairment sufficient to preclude adequate understanding of, or participation in, the trial procedures;
- Investigators, site staff, or other personnel directly involved in conduct of the study, and their immediate family members; employees of the Sponsor;
- Any condition that, in the investigator's judgment, would compromise participant safety or otherwise interfere with the assessment of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weiqing Wang
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Participants With Obesity
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of once-weekly HRS-4729 injection in adults with obesity without diabetes. Approximately 252 participants will be enrolled. The primary endpoint is percent change in body weight from baseline at Week 32 versus placebo.
- Conditions
- Overweight or Obesity
- Being tested
- HRS-4729 Injection, HRS-4729 Injection;, HRS-4729 Injection Placebo
- Medical subject headings
- Overweight, Obesity
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; Dose 1
HRS-4729 InjectionDrug
HRS-4729 Injection; Dose 2
HRS-4729 InjectionDrug
HRS-4729 Injection; Dose 3
HRS-4729 Injection;Drug
HRS-4729 Injection; Dose 4
HRS-4729 Injection;Drug
HRS-4729 Injection; Dose 5
HRS-4729 Injection;Drug
HRS-4729 Injection; Dose 6
HRS-4729 Injection PlaceboDrug
HRS-4729 Injection Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Drug: HRS-4729 Injection Receives: Drug: HRS-4729 Injection |
| Dose 2 | Experimental | Drug: HRS-4729 Injection Receives: Drug: HRS-4729 Injection |
| Dose 3 | Experimental | Drug: HRS-4729 Injection Receives: Drug: HRS-4729 Injection |
| Dose 4 | Experimental | Drug: HRS-4729 Injection Receives: Drug: HRS-4729 Injection; |
| Dose 5 | Experimental | Drug: HRS-4729 Injection Receives: Drug: HRS-4729 Injection; |
| Dose 6 | Experimental | Drug: HRS-4729 Injection Receives: Drug: HRS-4729 Injection; |
| Placebo | Placebo comparator | Drug: HRS-4729 Injection Placebo Receives: Drug: HRS-4729 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight
Measured: Baseline, Week 32
Secondary outcomes (7)
Percent Change From Baseline in Body Weight
Measured: Baseline, Week 40
Change From Baseline in Body Weight
Measured: Baseline, Week 32 and 40
Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 32 and 40
Change from Baseline in Waist Circumference
Measured: Baseline, Week 32 and 40
Change from Baseline in Blood Pressure
Measured: Baseline, Week 32 and 40
Change from Baseline in Glucose Level
Measured: Baseline, Week 32 and 40
TEAEs
Measured: Baseline, Week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionMar 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 Overweight or ObesityStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 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
- NCT07690826
- Sponsor's protocol ID
- HRS-4729-202
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Participants With Obesity
- ClinicalTrials.gov ID
- NCT07690826
- Acronym / sponsor ID
- HRS-4729-202
- Conditions
- Overweight or Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Jul 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.
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of once-weekly HRS-4729 injection in adults with obesity without diabetes. Approximately 252 participants will be enrolled. The primary endpoint is percent change in body weight from baseline at Week 32 versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: HRS-4729 InjectionDrug: HRS-4729 Injection |
| Dose 2 | Experimental | Drug: HRS-4729 InjectionDrug: HRS-4729 Injection |
| Dose 3 | Experimental | Drug: HRS-4729 InjectionDrug: HRS-4729 Injection |
| Dose 4 | Experimental | Drug: HRS-4729 Injection;Drug: HRS-4729 Injection |
| Dose 5 | Experimental | Drug: HRS-4729 Injection;Drug: HRS-4729 Injection |
| Dose 6 | Experimental | Drug: HRS-4729 Injection;Drug: HRS-4729 Injection |
| Placebo | Placebo comparator | Drug: HRS-4729 Injection PlaceboDrug: HRS-4729 Injection Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to provide a written informed consent.
- Male or female adults aged 18 to 65 years.
- BMI: 28.0 to 40.0 kg/m2.
- Self-reported diet and exercise control for at least 3 months before screening, with body weight change of no more than 5 kg during the previous 3 months.
Key exclusion criteria (15 listed)
- Endocrine disease or history that may have a significant effect on body weight;
- History of diabetes mellitus (gestational diabetes excepted);
- Malignancy of any organ system within the past 5 years, irrespective of evidence of local recurrence or metastasis, except for adequately treated localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, and prostate carcinoma in situ;
- Presence or suspicion of depression, anxiety disorder, bipolar disorder, suicidal ideation, schizophrenia, or other clinically significant psychiatric disorder, or a history of suicide attempt;
- Known or suspected excessive alcohol use, or a history of alcohol, drug, or substance abuse;
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; Dose 1 | Drug | Dose 1 |
| HRS-4729 InjectionHRS-4729 Injection; Dose 2 | Drug | Dose 2 |
| HRS-4729 InjectionHRS-4729 Injection; Dose 3 | Drug | Dose 3 |
| HRS-4729 Injection;HRS-4729 Injection; Dose 4 | Drug | Dose 4 |
| HRS-4729 Injection;HRS-4729 Injection; Dose 5 | Drug | Dose 5 |
| HRS-4729 Injection;HRS-4729 Injection; Dose 6 | Drug | Dose 6 |
| HRS-4729 Injection PlaceboHRS-4729 Injection Placebo | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 32
7 secondary outcomes
Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 40
Change From Baseline in Body Weight
Time frame: Baseline, Week 32 and 40
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 32 and 40
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 32 and 40
Change from Baseline in Blood Pressure
Time frame: Baseline, Week 32 and 40
Change from Baseline in Glucose Level
Time frame: Baseline, Week 32 and 40
TEAEs
Time frame: Baseline, Week 44
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 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Overweight or Obesity
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
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.
1 site 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 HRS-4729 Injection; in people with Overweight or Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site 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 4 inclusion and 15 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Ziwei Du (+86 0518-81220121, ziwei.du.zd9@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Body Weight (time frame: Baseline, Week 32). 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 8 Jul 2026.