Body Weight ManagementPhase 1NCT07826364
A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Study of SHR-1179 Injection in Participants With Obesity
A Phase 1 study of Body Weight Management, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study is a single-center, randomized, double-blind, dose-escalation, placebo-parallel-controlled Phase I clinical trial. The primary objective is to evaluate the safety and tolerability of a single subcutaneous injection of SHR-1179 in obese participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Sep 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female participants aged ≥ 18 and ≤ 60 years at the time of informed consent signing;
- Male participants weighing ≥ 50.0 kg, female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 28.0 and 35.0 kg/m² (inclusive), where BMI = weight (kg) / height² (m²);
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening and Baseline. Female participants of childbearing potential or male participants with partners of childbearing potential must agree to avoid sperm/egg donation and practice highly effective contraception (including their partners) from the signing of the ICF until the completion of the safety follow-up period following the last dose (see Appendix 1);
- Negative HIV antibody (HIV-Ab) test result at Screening;
- Ability to understand the study procedures and requirements, willingness to participate voluntarily, and provide written informed consent.
Who cannot join
- Have a documented history of diseases involving the immune system, central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematologic system, etc., or other conditions that, in the investigator's opinion, make the participant unsuitable for participation in this clinical trial (e.g., psychiatric history, etc.);
- Have a history of drug or other allergies, or, in the investigator's judgment, may be allergic to the investigational product or any of its components;
- Have undergone major surgery within 3 months prior to Screening, or have undergone surgery that may significantly affect the in vivo disposition of the investigational product or the safety evaluation, or plan to undergo surgery during the trial period;
- Have participated in any clinical trial as a participant within 3 months prior to Screening, or plan to participate in other clinical trials during the course of this study;
- Have experienced blood loss or donated blood > 400 mL (excluding menstrual blood loss in females), received blood transfusion or blood products within 3 months prior to Screening, or plan to donate blood during the trial or within 1 month after the end of the trial.
- Have experienced a body weight change of > 5% within 3 months prior to Screening, or have used GLP-1 receptor agonists, weight-loss drugs, or systemic corticosteroids (oral or intravenous administration for more than 7 days) within 3 months prior to Screening;
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- Have any laboratory abnormalities meeting the following criteria at Screening, or have clinically significant abnormalities in vital signs, physical examinations, or laboratory tests specified in this protocol as judged by the investigator:
- Have 12-lead electrocardiogram (ECG) findings at Screening showing atrioventricular block (excluding clinically insignificant first-degree atrioventricular block), atrial fibrillation, or atrial flutter, or QTcF ≥ 450 ms (males) or ≥ 470 ms (females), or other abnormalities judged by the investigator to be clinically significant;
- Have chest X-ray (posteroanterior view) or abdominal ultrasound findings at Screening judged by the investigator to be clinically significant abnormalities;
- Have positive results at Screening for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), or Treponema pallidum antibody (Anti-TP).
- Have used or are currently using any prescription drugs or over-the-counter (OTC) medications within 2 weeks prior to dosing; or have taken functional vitamins, health supplements, or herbal products; or are known to require other medication during the trial period;
- Have consumed excessive amounts of tea, coffee, or caffeinated beverages (average > 8 cups per day, 250 mL per cup) within 3 months prior to Screening;
- Have consumed special foods (e.g., grapefruit, grapefruit juice, or food/beverages containing grapefruit juice, chocolate, tobacco, alcohol, caffeinated products, etc.) within 48 hours prior to dosing;
- Have a history of regular alcohol consumption (i.e., > 14 standard units per week within 3 months prior to Screening, where 1 standard unit contains 14 g of alcohol, equivalent to 360 mL of beer, 45 mL of 40% spirit, or 150 mL of wine), or are unable to abstain from alcohol during the trial; or have a positive alcohol breath test;
- Have an average daily smoking history of > 5 cigarettes per day within 3 months prior to Screening, or are unable to abstain from smoking during the trial;
- Have been on a diet or received weight-loss treatment (for any reason) within 2 months prior to Screening, or have had significant changes in lifestyle habits;
- Have a history of drug abuse or substance use; or have a positive result on drug abuse screening (including MDMA, methamphetamine, cocaine, morphine, ketamine, and THC acid);
- Are pregnant or lactating females;
- Have difficulty with venous blood sampling, are unable to tolerate venipuncture, or have a history of needle or blood phobia;
- Have a history of severe cardiovascular disease, such as decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, myocardial infarction, or have undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
- Participants who, in the opinion of the investigator, may be unable to complete the study for other reasons, or who are considered unsuitable for enrollment by the investigator.
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
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xiaoying Li
Hongrong Xu
About this study
Official title: A Randomized, Double-blind, Dose-escalation, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous SHR-1179 Injection in Obese Participants."
This study is a single-center, randomized, double-blind, dose-escalation, placebo-parallel-controlled Phase I clinical trial. The primary objective is to evaluate the safety and tolerability of a single subcutaneous injection of SHR-1179 in obese participants. For the single-ascending-dose (SAD) part in obese participants, a total of 5 dose cohorts are planned for the single-dose escalation.
- Conditions
- Body Weight Management
- Being tested
- SHR-1179 ; Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1179 ; PlaceboDrug
Dose 1 SHR-1179+Placebo low dose
SHR-1179 ; PlaceboDrug
Dose 2 SHR-1179+Placebo low dose
SHR-1179 ; PlaceboDrug
Dose 3 SHR-1179+Placebo medium dose
SHR-1179 ; PlaceboDrug
Dose 4 SHR-1179+Placebo high dose
SHR-1179 ; PlaceboDrug
Dose 5 SHR-1179+Placebo high dose
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 SHR-1179+Placebo | Experimental | Not described Receives: Drug: SHR-1179 ; Placebo |
| Dose 2 SHR-1179+Placebo | Experimental | Not described Receives: Drug: SHR-1179 ; Placebo |
| Dose 3 SHR-1179+Placebo | Experimental | Not described Receives: Drug: SHR-1179 ; Placebo |
| Dose 4 SHR-1179+Placebo | Experimental | Not described Receives: Drug: SHR-1179 ; Placebo |
| Dose 5 SHR-1179+Placebo | Experimental | Not described Receives: Drug: SHR-1179 ; Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: from pre-dose to 10 months post-dose.
Secondary outcomes (7)
Serum concentration of SHR-1179 after single-dose administration.
Measured: from pre-dose to 10 months post-dose.
AUC of SHR 1179 after single administration（AUC0-last, AUC0-inf ）
Measured: from pre-dose to 10 months post-dose.
Time to peak concentration（Tmax）
Measured: from pre-dose to 10 months post-dose.
Peak concentration （Cmax）
Measured: from pre-dose to 10 months post-dose.
Elimination half-life （T1/2）
Measured: from pre-dose to 10 months post-dose.
Apparent clearance (CL/F)
Measured: from pre-dose to 10 months post-dose.
Apparent volume of distribution (V/F)
Measured: from pre-dose to 10 months post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ManagementStudies of the same condition, open and under way.
- 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, dose-escalation, placebo-controlled Phase I clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826364
- Sponsor's protocol ID
- SHR-1179-101
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2026
- Last updated
- 17 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Dose-escalation, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous SHR-1179 Injection in Obese Participants."
- ClinicalTrials.gov ID
- NCT07826364
- Acronym / sponsor ID
- SHR-1179-101
- Conditions
- Body Weight Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 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 single-center, randomized, double-blind, dose-escalation, placebo-parallel-controlled Phase I clinical trial. The primary objective is to evaluate the safety and tolerability of a single subcutaneous injection of SHR-1179 in obese participants. For the single-ascending-dose (SAD) part in obese participants, a total of 5 dose cohorts are planned for the single-dose escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- randomized, double-blind, dose-escalation, placebo-controlled Phase I clinical trial
| Arm | Type | Receives |
|---|---|---|
| Dose 1 SHR-1179+Placebo | Experimental | Drug: SHR-1179 ; Placebo |
| Dose 2 SHR-1179+Placebo | Experimental | Drug: SHR-1179 ; Placebo |
| Dose 3 SHR-1179+Placebo | Experimental | Drug: SHR-1179 ; Placebo |
| Dose 4 SHR-1179+Placebo | Experimental | Drug: SHR-1179 ; Placebo |
| Dose 5 SHR-1179+Placebo | Experimental | Drug: SHR-1179 ; Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female participants aged ≥ 18 and ≤ 60 years at the time of informed consent signing;
- Male participants weighing ≥ 50.0 kg, female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 28.0 and 35.0 kg/m² (inclusive), where BMI = weight (kg) / height² (m²);
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening and Baseline. Female participants of childbearing potential or male participants with partners of childbearing potential must agree to avoid sperm/egg donation and practice highly effective contraception (including their partners) from the signing of the ICF until the completion of the safety follow-up period following the last dose (see Appendix 1);
- Negative HIV antibody (HIV-Ab) test result at Screening;
- Ability to understand the study procedures and requirements, willingness to participate voluntarily, and provide written informed consent.
Key exclusion criteria (21 listed)
- Have a documented history of diseases involving the immune system, central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematologic system, etc., or other conditions that, in the investigator's opinion, make the participant unsuitable for participation in this clinical trial (e.g., psychiatric history, etc.);
- Have a history of drug or other allergies, or, in the investigator's judgment, may be allergic to the investigational product or any of its components;
- Have undergone major surgery within 3 months prior to Screening, or have undergone surgery that may significantly affect the in vivo disposition of the investigational product or the safety evaluation, or plan to undergo surgery during the trial period;
- Have participated in any clinical trial as a participant within 3 months prior to Screening, or plan to participate in other clinical trials during the course of this study;
- Have experienced blood loss or donated blood > 400 mL (excluding menstrual blood loss in females), received blood transfusion or blood products within 3 months prior to Screening, or plan to donate blood during the trial or within 1 month after the end of the trial.
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 |
|---|---|---|
| SHR-1179 ; PlaceboDose 1 SHR-1179+Placebo low dose | Drug | Dose 1 SHR-1179+Placebo |
| SHR-1179 ; PlaceboDose 2 SHR-1179+Placebo low dose | Drug | Dose 2 SHR-1179+Placebo |
| SHR-1179 ; PlaceboDose 3 SHR-1179+Placebo medium dose | Drug | Dose 3 SHR-1179+Placebo |
| SHR-1179 ; PlaceboDose 4 SHR-1179+Placebo high dose | Drug | Dose 4 SHR-1179+Placebo |
| SHR-1179 ; PlaceboDose 5 SHR-1179+Placebo high dose | Drug | Dose 5 SHR-1179+Placebo |
Primary outcome
Adverse events
Time frame: from pre-dose to 10 months post-dose.
7 secondary outcomes
Serum concentration of SHR-1179 after single-dose administration.
Time frame: from pre-dose to 10 months post-dose.
AUC of SHR 1179 after single administration（AUC0-last, AUC0-inf ）
Time frame: from pre-dose to 10 months post-dose.
Time to peak concentration（Tmax）
Time frame: from pre-dose to 10 months post-dose.
Peak concentration （Cmax）
Time frame: from pre-dose to 10 months post-dose.
Elimination half-life （T1/2）
Time frame: from pre-dose to 10 months post-dose.
Apparent clearance (CL/F)
Time frame: from pre-dose to 10 months post-dose.
Apparent volume of distribution (V/F)
Time frame: from pre-dose to 10 months post-dose.
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 17 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 of Body Weight Management, run by Guangdong Hengrui 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 5 inclusion and 21 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 17 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. 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, MD. (18701973631, xuehu.gao@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: from pre-dose to 10 months post-dose.). 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 17 Sep 2026.