Weight ManagementPhase 1NCT07841860
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets in Healthy Participants With a Single Dose and in Obese Participants With Multiple Doses
A Phase 1 study testing HRS-1596 in people with Weight Management and Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Management, Type 2 Diabetes
- What is being tested?
- HRS-1596
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to May 2027
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign the informed consent form before the commencement of the activities related to this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.
- The age range is from 18 to 55 years old (inclusive at both ends).
- Weight ≥ 50.0 kg.
- They must also not be in the lactation period. For male participants whose partners are fertile women, they must agree to voluntarily adopt medically approved highly effective contraceptive measures from the time of signing the informed consent form until 2 months after the last administration. They must have no intention to have children and must avoid donating sperm/eggs (including their partners).
Who cannot join
- During the screening process, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg were considered.
- The score of the Patient Health Questionnaire-9 (PHQ-9) during screening was ≥ 15 points.
- During the screening process, there may be cases where there are obvious endocrine diseases or medical histories that could significantly affect body weight (such as Cushing's syndrome, hypothyroidism or hyperthyroidism, etc.), or obesity caused by single gene mutations or hereditary obesity syndromes, etc.
- Diabetes (except gestational diabetes).
- Any malignant tumor of any organ system has occurred within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis (except for cured local basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ).
- Those who have had or currently have the following diseases with clinical significance (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cardiovascular diseases), and who, in the judgment of the investigators, are not suitable to participate in this trial.
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- Those who consumed more than 14 units of alcohol per week within the previous 6 months (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol content spirits or 150 mL of wine); or those who had taken any alcohol-containing products within 48 hours before the administration; or those with a positive alcohol breath test result.
- Screening criteria: Daily smoking quantity greater than 5 cigarettes within the past 3 months or use of any tobacco product within 48 hours prior to administration.
- Those with a known or suspected history of drug abuse or drug use; or those with a positive urine drug screening result.
- Unable to tolerate venipuncture for blood collection or experiencing fainting or nausea during the procedure.
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
Jinan Central Hospital
Jinan, Shandong, 250013
Qing Wen, +86-0531-55865012, wenq0619@126.com
Qing Wen
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets as a Single Dose in Healthy Participants and Multiple Doses in Obese Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study
This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese participants.
- Conditions
- Weight Management, Type 2 Diabetes
- Being tested
- HRS-1596, HRS-1596 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-1596Drug
HRS-1596.
HRS-1596 PlaceboDrug
HRS-1596 placebo.
| Study group | Role | What they receive |
|---|---|---|
| HRS-1596 Group | Experimental | HRS-1596, healthy subjects or obese subjects. Receives: Drug: HRS-1596 |
| HRS-1596 Placebo Group | Placebo comparator | HRS-1596 placebo, healthy subjects or obese subjects. Receives: Drug: HRS-1596 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events (AEs)
Measured: Screening period up to Day 84.
Secondary outcomes (5)
The maximum plasma concentration (Cmax)
Measured: Post-dose at Day 1 to Day 84.
Time to maximum plasma concentration (Tmax)
Measured: Post-dose at Day 1 to Day 84.
Terminal half-life (t1/2)
Measured: Post-dose at Day 1 to Day 84.
Anti-HRS-1596 Antibodies (ADAs)
Measured: Post-dose at Day 1 to Day 84.
Fasting plasma glucose (FPG)
Measured: Post-dose at Day 1 to Day 84.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, dose escalation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 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
- NCT07841860
- Sponsor's protocol ID
- HRS-1596-101
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets as a Single Dose in Healthy Participants and Multiple Doses in Obese Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study
- ClinicalTrials.gov ID
- NCT07841860
- Acronym / sponsor ID
- HRS-1596-101
- Conditions
- Weight Management, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 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.
This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, dose escalation.
| Arm | Type | Receives |
|---|---|---|
| HRS-1596 Group | Experimental | Drug: HRS-1596HRS-1596, healthy subjects or obese subjects. |
| HRS-1596 Placebo Group | Placebo comparator | Drug: HRS-1596 PlaceboHRS-1596 placebo, healthy subjects or obese subjects. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntarily sign the informed consent form before the commencement of the activities related to this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.
- The age range is from 18 to 55 years old (inclusive at both ends).
- Weight ≥ 50.0 kg.
- They must also not be in the lactation period. For male participants whose partners are fertile women, they must agree to voluntarily adopt medically approved highly effective contraceptive measures from the time of signing the informed consent form until 2 months after the last administration. They must have no intention to have children and must avoid donating sperm/eggs (including their partners).
Key exclusion criteria (10 listed)
- During the screening process, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg were considered.
- The score of the Patient Health Questionnaire-9 (PHQ-9) during screening was ≥ 15 points.
- During the screening process, there may be cases where there are obvious endocrine diseases or medical histories that could significantly affect body weight (such as Cushing's syndrome, hypothyroidism or hyperthyroidism, etc.), or obesity caused by single gene mutations or hereditary obesity syndromes, etc.
- Diabetes (except gestational diabetes).
- Any malignant tumor of any organ system has occurred within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis (except for cured local basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ).
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-1596HRS-1596. | Drug | HRS-1596 Group |
| HRS-1596 PlaceboHRS-1596 placebo. | Drug | HRS-1596 Placebo Group |
Primary outcome
The incidence and severity of adverse events (AEs)
Time frame: Screening period up to Day 84.
5 secondary outcomes
The maximum plasma concentration (Cmax)
Time frame: Post-dose at Day 1 to Day 84.
Time to maximum plasma concentration (Tmax)
Time frame: Post-dose at Day 1 to Day 84.
Terminal half-life (t1/2)
Time frame: Post-dose at Day 1 to Day 84.
Anti-HRS-1596 Antibodies (ADAs)
Time frame: Post-dose at Day 1 to Day 84.
Fasting plasma glucose (FPG)
Time frame: Post-dose at Day 1 to Day 84.
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 25 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-1596 in people with Weight Management and Type 2 Diabetes, 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 10 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 25 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xuehu Gao (+86-0518-82342973, xuehu.gao@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events (AEs) (time frame: Screening period up to Day 84.). 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 25 Sep 2026.