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
- Chronic Weight Management
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Ascletis Pharma (China) Co., Limited
- Enrolment target
- 84
- Started
- 27 August 2026
- Main results due
- June 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 65 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Have evidence of any clinically significant active or chronic disease. * Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma. * Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. * Have a history of acute or chronic pancreatitis. * Have a known clinically significant gastric emptying abnormality. * 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.
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(1)
Ascletis Clinical Site
Baltimore, Maryland, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07842640. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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