Early test of ASC35, a monthly injection, in adults with obesity or overweight
Tests the safety of ASC35 injections in adults with obesity or overweight.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight
Key facts
- Where
- Baltimore, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07842640, who can take part
Where in United States
- BaltimoreBaltimore, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ascletis Pharma (China) Co., Limited
- Trial code
- NCT07842640
- Record updated
- 25 September 2026
- Original description
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 injectionRead full original descriptionShow less
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
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
Inclusion: 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: Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma; 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; Have a known clinically significant gastric emptying abnormality.