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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
Who can join
Ages 18 to 65 · All sexes · Healthy volunteers welcome
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.
About the study
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
What is being tested
- ASC35 Injection B, for subcutaneous use (drug)
- ASC35 Placebo Injection B, for subcutaneous use (drug)
- Tirzepatide (drug)
Sponsor: Ascletis Pharma (China) Co., Limited · Participants: 84 · Started: Aug 27, 2026
Contact the study team
- Ascletis Recruiting · Phone: +1 2068073688
Official record on ClinicalTrials.gov — NCT07842640
Locations in the U.S.
| Maryland | Ascletis Clinical Site, Baltimore |
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.