NCT07842640RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight
A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 21 Sept 2026
- Start date
- 27 Aug 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Ascletis Pharma (China) Co., Limited
- Diseases
- Obesity
- NCT number
- NCT07842640
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 84
- From 27 Aug 2026 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
Other illness
- Have evidence of any clinically significant active or chronic disease.
- Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- Have a history of acute or chronic pancreatitis.
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
- Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
Other
- Have a known clinically significant gastric emptying abnormality.
Who the study is looking for
- Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site.
- Are between 18 and 65 years of age (both inclusive) at time of screening.
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.