ObesityPhase 2NCT06287437
HRS9531 Controls Weight Regain in Obese Subjects
A Phase 2 study testing HRS9531 in people with Obesity, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is a single-center, double-blinded, randomized, placebo-controlled phase II study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of HRS9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- HRS9531
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30-60 years old, female and male.
- BMI:30-40kg/m2.
- Non diabetes or type 2 diabetes with HbA1c between 7-10%.
Who cannot join
- Weight change ≤5 kg within 3 months.
- Hb<110g/L.
- Serum triglycerides 5.7 mmol/L.
- Impaired liver function ：ALT or AST≥3×ULN，TB≥2×ULN.
- Impaired renal function：eGFT < 45 ml/min.
- Hemodiastase or Serum lipase≥3×ULN.
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- TSH>6.0 mIU/L or<0.4 mIU/L.
- Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
- lth Questionnaire-9 (PHQ-9) score ≥15.
- Type 1 diabetes.
- Proliferative diabetic retinopathy, ketoacidosis or hyperglycemia hypertonic state within 3 months.
- In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Double-blinded, Randomized, Placebo-controlled Trial to Evaluate the Effectiveness and Safety of Low-frequency Injection of HRS9531 in Control of Weight Regain in Obese Subjects With and Without Diabetes
This is a single-center, double-blinded, randomized, placebo-controlled phase II study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of HRS9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients
- Conditions
- Obesity
- Being tested
- HRS9531, HRS9531 placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531Drug
HRS9531 escalated to the protocol-specified dose once weekly injection for 24 weeks ，then low frequency injection for 12 weeks.
HRS9531 placeboDrug
HRS9531 placebo low frequency injection for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The subjects receive sequential once weekly and low frequency subcutaneous injection of HRS 9531 Receives: Drug: HRS9531 |
| Control | Placebo comparator | The subjects receive low frequency subcutaneous injection of the placebo Receives: Drug: HRS9531 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight from 24 weeks
Percentage change in body weight from the low-frequency injection phase for HRS9531 compared with placebo
Measured: 36 weeks
Secondary outcomes (15)
Energy intake change from 24 weeks
Differences in energy intake changes between the HRS9531 group and the placebo group from week36-week24
Measured: 24-36 weeks
Energy expenditure change from 24 weeks
Differences in energy expenditure changes between the HRS9531 group and the placebo group from week36-week24
Measured: 24-36 weeks
Metabolic adaptation from 24 weeks
Differences in metabolic adaptation changes between the HRS9531 group and the placebo group from week36-week24（Metabolic adaptation=Actual measured resting energy expenditure-Predicted resting energy expenditure. The Actual measured resting energy expenditure will be measured using the Maastricht Instruments Room Calorimeter ADVANCE. The predicted energy expenditure will be fitted by multiple linear regression according to the age, sex, and body composition information of the subjects at baseline.）
Measured: 24-36 weeks
Systolic blood pressure and diastolic blood pressure change from 24 weeks
Differences in systolic blood pressure and diastolic blood pressure changes between the HRS9531 group and the placebo group from week36-week24
Measured: 24-36 weeks
Body fat rate change from 24 weeks
Differences in body fat rate changes between the HRS9531 group and the placebo group from week36-week24
Measured: 24-36 weeks
Serum total cholesterol change from 24 weeks
Differences in Serum total cholesterol changes between the HRS9531 group and the placebo group from week36-week24
Measured: 24-36 weeks
Triglyceride change from 24 weeks
Differences in Triglyceride changes between the HRS9531 group and the placebo group from week36-week24
Measured: 24-36 weeks
Nonestesterified fatty acid change from 24 weeks
Differences in nonestesterified fatty acid changes between the HRS9531 group and the placebo group from week36-week24
Measured: 24-36 weeks
Energy intake at baseline
Differences in energy intake at baseline in obese diabetic subjects, relative to obese non-diabetic subjects.
Measured: 0 weeks
Energy expenditure at baseline
Differences in energy expenditure at baseline in obese diabetic subjects, relative to obese non-diabetic subjects.
Measured: 0 weeks
Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale)
Differences in appetite at baseline in obese diabetic subjects, relative to obese non-diabetic subjects (Appetite was assessed using the Visual Analogue Scale subjective rating scale. On a standard scale of 100mm in length, the left end (0mm) means "not at all" and the right end (100mm) means "extremely").
Measured: 0 weeks
Percent Change in Body Weight at 24 weeks
Obese diabetic subjects, relative to obese non-diabetic subjects, difference in body weight change after once weekly injection of HRS9531
Measured: 24 weeks
Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale)
Obese diabetic subjects, relative to obese non-diabetic subjects, difference in appetite after once weekly injection of HRS9531(Appetite was assessed using the Visual Analogue Scale subjective rating scale. On a standard scale of 100mm in length, the left end (0mm) means "not at all" and the right end (100mm) means "extremely").
Measured: 24 weeks
Energy expenditure at 24 weeks
Obese diabetic subjects, relative to obese non-diabetic subjects, difference in energy expenditure after once weekly injection of HRS9531
Measured: 24 weeks
Energy intake at 24 weeks
Obese diabetic subjects, relative to obese non-diabetic subjects, difference in Energy intake after once weekly injection of HRS9531
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoying Li, Shanghai Zhongshan Hospital
- Investigators
- Xiaoying Li, MD, Principal investigator, Zhongshan Hosptial, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287437
- Sponsor's protocol ID
- B2023-335R
- Status last verified
- Feb 2024
- First submitted
- 2 Jan 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Double-blinded, Randomized, Placebo-controlled Trial to Evaluate the Effectiveness and Safety of Low-frequency Injection of HRS9531 in Control of Weight Regain in Obese Subjects With and Without Diabetes
- ClinicalTrials.gov ID
- NCT06287437
- Acronym / sponsor ID
- B2023-335R
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Mar 2024 (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 single-center, double-blinded, randomized, placebo-controlled phase II study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of HRS9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: HRS9531The subjects receive sequential once weekly and low frequency subcutaneous injection of HRS 9531 |
| Control | Placebo comparator | Drug: HRS9531 placeboThe subjects receive low frequency subcutaneous injection of the placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 30-60 years old, female and male.
- BMI:30-40kg/m2.
- Non diabetes or type 2 diabetes with HbA1c between 7-10%.
Key exclusion criteria (12 listed)
- Weight change ≤5 kg within 3 months.
- Hb<110g/L.
- Serum triglycerides 5.7 mmol/L.
- Impaired liver function ：ALT or AST≥3×ULN，TB≥2×ULN.
- Impaired renal function：eGFT < 45 ml/min.
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 |
|---|---|---|
| HRS9531HRS9531 escalated to the protocol-specified dose once weekly injection for 24 weeks ，then low frequency injection for 12 weeks. | Drug | Intervention |
| HRS9531 placeboHRS9531 placebo low frequency injection for 12 weeks. | Drug | Control |
Primary outcome
Percent Change in Body Weight from 24 weeks
Time frame: 36 weeks
Percentage change in body weight from the low-frequency injection phase for HRS9531 compared with placebo
15 secondary outcomes
Energy intake change from 24 weeks
Time frame: 24-36 weeks
Energy expenditure change from 24 weeks
Time frame: 24-36 weeks
Metabolic adaptation from 24 weeks
Time frame: 24-36 weeks
Systolic blood pressure and diastolic blood pressure change from 24 weeks
Time frame: 24-36 weeks
Body fat rate change from 24 weeks
Time frame: 24-36 weeks
Serum total cholesterol change from 24 weeks
Time frame: 24-36 weeks
Triglyceride change from 24 weeks
Time frame: 24-36 weeks
Nonestesterified fatty acid change from 24 weeks
Time frame: 24-36 weeks
Energy intake at baseline
Time frame: 0 weeks
Energy expenditure at baseline
Time frame: 0 weeks
Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale)
Time frame: 0 weeks
Percent Change in Body Weight at 24 weeks
Time frame: 24 weeks
Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale)
Time frame: 24 weeks
Energy expenditure at 24 weeks
Time frame: 24 weeks
Energy intake at 24 weeks
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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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. This study is not recruiting at the moment.
Xiaoying Li, MD principal investigator
Zhongshan Hosptial, Fudan University
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 HRS9531 in people with Obesity, run by Shanghai Zhongshan Hospital 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight from 24 weeks (time frame: 36 weeks). 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 1 Mar 2024.