Evaluating LAE102 in healthy and overweight individuals
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LAE102 Injection in Healthy and Overweight/Obese Subjects
Run by Laekna Limited · NCT06493084 · Data updated 2026-11-12
This study is testing a new drug called LAE102 to see how safe it is and how the body handles it in both healthy people and those who are overweight or obese.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Laekna Limited Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | June 25, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT06493084 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include healthy individuals aged 18 to 65 with a BMI within specified ranges, as well as overweight/obese individuals meeting the study criteria.
✕Probably not a fit
Patients with significant health abnormalities or allergies to the investigational drug may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety, tolerability, and pharmacokinetics of LAE102 through various administration methods in both healthy and overweight/obese participants. It consists of three parts: Part A involves a single ascending dose via intravenous administration in healthy participants, Part B involves a similar approach with subcutaneous administration, and Part C evaluates multiple doses in overweight/obese participants. The study is randomized, double-blinded, and placebo-controlled to ensure reliable results.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for managing overweight and obesity.
How similar studies have gone: Other studies have shown promise in evaluating similar pharmacological approaches, but this specific intervention is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Fudan Zhongshan Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Xuening Li, Professor — Zhongshan hospital affiliated to Fundan University
- Study coordinator: Li Qiu, BS
- Email: li.qiu@laekna.com
- Phone: +8617310793626
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.