ClinicalTrials.gg
Not yet recruitingNCT07826364Updated Sep 17, 2026

A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Study of SHR-1179 Injection in Participants With Obesity

A Phase 1 interventional study of SHR-1179 ; Placebo and SHR-1179 ; Placebo in Body Weight Management, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. For the single-ascending-dose (SAD) part in obese participants, a total of 5 dose cohorts are planned for the single-dose escalation.

02

Conditions studied

  • Body Weight Management
03

In context

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 59 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male or female participants aged ≥ 18 and ≤ 60 years at the time of signing;
  2. Male participants weighing ≥ 50.0 kg, female participants weighing ≥ 45.0 kg, with a (BMI) between 28.0 and 35.0 kg/m² (inclusive), where BMI = weight (kg) / height² (m²);
  3. Female participants of 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 (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);
  4. Negative antibody (HIV-Ab) test result at Screening;
  5. Ability to understand the study procedures and requirements, willingness to participate voluntarily, and provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. 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.);
  2. Have a history of drug or other allergies, or, in the investigator's judgment, may be allergic to the product or any of its components;
  3. 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;
  4. 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;
  5. 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.
  6. 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 (oral or intravenous administration for more than 7 days) within 3 months prior to Screening;
  7. Have any laboratory abnormalities meeting the following criteria at Screening, or have abnormalities in vital signs, physical examinations, or laboratory tests specified in this protocol as judged by the investigator:
  8. Have 12-lead (ECG) findings at Screening showing atrioventricular block (excluding clinically insignificant first-degree atrioventricular block), atrial fibrillation, or atrial flutter, or ≥ 450 ms (males) or ≥ 470 ms (females), or other abnormalities judged by the investigator to be clinically significant;
  9. Have chest X-ray (posteroanterior view) or abdominal ultrasound findings at Screening judged by the investigator to be clinically significant abnormalities;
  10. Have positive results at Screening for any of the following: surface antigen (HBsAg), virus antibody (HCV-Ab), or Treponema pallidum antibody (Anti-TP).
  11. 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;
  12. 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;
  13. 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;
  14. 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;
  15. 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;
  16. 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;
  17. 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);
  18. Are pregnant or lactating females;
  19. Have difficulty with venous blood sampling, are unable to tolerate venipuncture, or have a history of needle or blood phobia;
  20. Have a history of severe cardiovascular disease, such as decompensated heart failure ( [NYHA] Class III-IV), unstable angina pectoris, myocardial infarction, or have undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
  21. 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.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Dose 1 SHR-1179+Placebo

    Drug: SHR-1179 ; Placebo

  • Experimental
    Dose 2 SHR-1179+Placebo

    Drug: SHR-1179 ; Placebo

  • Experimental
    Dose 3 SHR-1179+Placebo

    Drug: SHR-1179 ; Placebo

  • Experimental
    Dose 4 SHR-1179+Placebo

    Drug: SHR-1179 ; Placebo

  • Experimental
    Dose 5 SHR-1179+Placebo

    Drug: SHR-1179 ; Placebo

Interventions

  • DrugSHR-1179 ; Placebo

    Dose 1 SHR-1179+Placebo low dose

  • DrugSHR-1179 ; Placebo

    Dose 2 SHR-1179+Placebo low dose

  • DrugSHR-1179 ; Placebo

    Dose 3 SHR-1179+Placebo medium dose

  • DrugSHR-1179 ; Placebo

    Dose 4 SHR-1179+Placebo high dose

  • DrugSHR-1179 ; Placebo

    Dose 5 SHR-1179+Placebo high dose

06

What researchers measure

Primary outcomes

  1. Adverse events

    Time frame: from pre-dose to 10 months post-dose.

Secondary outcomes

  1. Serum concentration of SHR-1179 after single-dose administration.

    Time frame: from pre-dose to 10 months post-dose.

  2. AUC of SHR 1179 after single administration(AUC0-last, AUC0-inf )

    Time frame: from pre-dose to 10 months post-dose.

  3. Time to peak concentration(Tmax)

    Time frame: from pre-dose to 10 months post-dose.

  4. Peak concentration (Cmax)

    Time frame: from pre-dose to 10 months post-dose.

  5. Elimination half-life (T1/2)

    Time frame: from pre-dose to 10 months post-dose.

  6. Apparent clearance (CL/F)

    Time frame: from pre-dose to 10 months post-dose.

  7. Apparent volume of distribution (V/F)

    Time frame: from pre-dose to 10 months post-dose.

07

Study locations

1 site
  • Zhongshan Hospital, Fudan University
    Shanghai, Shanghai Municipality 200032, China
    • Xiaoying Li · Principal investigator
    • Hongrong Xu · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2026
First posted
Sep 17, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07826364
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Xuehu Gao, MD.
Contact
xuehu.gao@hengrui.com
18701973631
Hongda Lin, PhD.
Contact
hongda.lin@hengrui.com
17721286186

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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