New Weight-Loss shot enters human testing
NCT ID NCT06493084
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new drug called LAE102, given as an injection, in healthy volunteers and people who are overweight or obese. The main goal is to check if the drug is safe and how the body processes it. Researchers will also look for early signs of weight-related effects. The study involves 160 participants and is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LAE102 injection
- What this could lead to
- If this early trial shows LAE102 is safe, it could lead to a new injectable medication for weight management in people who are overweight or obese.
- What could go wrong
- This is a very early Phase 1 study with only 160 participants, focused on safety and dosing. It is not designed to prove weight loss, and many drugs fail at this stage.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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. Male or female and aged 18 to 65 years (inclusive) at the screening visit 2. Male Body weight ≥ 50 kg, female Body weight ≥ 45 kg. For Part A\&B, 18.5 ≤ BMI ≤ 28 kg/m². For part C, 26.0 ≤ BMI ≤ 40.0 kg/m² 3. Negative for human immunodeficiency virus antibody (HIV-Ab). 4. Female subjects with no childbearing potential or with childbearing potential which serum human chorionic gonadotropin (hCG) test must \<5mIU/mL . 5. Male subjects are not allowed to donate sperm during this trial. 6. Voluntarily participate in the study and provide a signed and dated informed consent form. 7. Willing to comply with the scheduled visits, study treatment, laboratory tests, and other study-related procedures and requirements as stipulated in the study protocol. Exclusion Criteria: 1. With clinically significant abnormalities in vital signs, physical examination, ECG or laboratory test results specified in the protocol. 2. Allergy to the investigational drug or its excipients, or a history of severe allergy (including any food or drug allergies). 3. Self-reported weight change is more than 5% in the previous 3 months prior to screening. 4. Diagnosed with secondary overweight or obesity. 5. Any clinically significant medical conditions and any diseases affecting the safety of the subject or the determination of study results. 6. History of major diseases or physical conditions in the central nervous system, respiratory system, cardiovascular system, digestive system, blood system, endocrine system, musculoskeletal diseases, mental illness, urinary system, or tumors, or any existing acute diseases, or other diseases or physical conditions that may affect the study or pose an unacceptable risk to the subjects. 7. Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or syphilis spirochete antibody (TP-Ab). 8. Known or suspected history of substance abuse or positive drug screening test. 9. Alcohol abuse within 1 year before screening or positive alcohol breath test at baseline. 10. Smoking more than 5 cigarettes per day within 3 months before screening, or unable to comply with the prohibition of smoking during the study period. 11. Received any vaccine within 30 days prior to screening, or planned to receive any vaccine during the study period. 12. Inability to ensure no use of any drugs, including prescription and non-prescription drugs (excluding paracetamol, ibuprofen, and topically applied eye/nasal drops and ointments with no systemic exposure risk), vitamins, supplements and herbal medicines, from 14 days before the initial administration (if the half-life of the drug used exceeds 14 days, then 5 half-lives shall apply) until the last visit period. 13. Participated in any clinical trial and received an investigational medicine or medical device within 3 months prior to dosing of the investigational product. 14. Underwent major surgery within 30 days before the initial administration or planned to undergo major surgery during the study period. 15. Donated blood or experienced blood loss ≥400 mL within 3 months before screening or received a blood transfusion. 16. Have special dietary requirements and cannot comply with a standardized diet. 17. History of fainting or syncope. 18. Dieting or receiving weight loss treatment within 30 days before the initial administration or experiencing major changes in lifestyle. 19. Use of GLP-1 receptor agonists, or weight loss medications or systemic corticosteroids (oral or intravenous for more than 7 days), or psychiatric medications within 3 months prior to the initial administration. Applicable to part C. 20. Regular engaged in muscle strength related exercise, applicable to part C. 21. Other situation that the investigator considers not appropriate.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fudan Zhongshan Hospital
RECRUITINGShanghai, Shanghai Municipality, 201203, China
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