New injection for obesity tested for safety in first human trial

NCT ID NCT07826364

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing an experimental injectable drug called SHR-1179 in obese adults. The trial aims to see how safe and tolerable a single dose is, and how the body processes the drug. About 50 participants with a body mass index between 28 and 35 will receive either SHR-1179 or a placebo as a shot under the skin. The study measures side effects and blood levels of the drug over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental injectable drug called SHR-1179
What this could lead to
If it works, this could point toward a new injectable treatment for obesity that doctors give less often.
What could go wrong
This is a first-in-human Phase I trial with about 50 participants, so researchers mainly check safety and drug levels, not weight loss. Many experimental drugs fail at this stage, and side effects may appear.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy male or female participants aged ≥ 18 and ≤ 60 years at the time of informed consent signing; 2. 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); 3. 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); 4. Negative HIV 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: 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 investigational 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 corticosteroids (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 clinically significant abnormalities in vital signs, physical examinations, or laboratory tests specified in this protocol as judged by the investigator: 8. 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; 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: hepatitis B surface antigen (HBsAg), hepatitis C 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 (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). 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032, China

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