RecruitingPhase 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

Lead sponsor

Ascletis Pharma (China) Co., Limited

Assets

ASC35 / Tirzepatide

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

Primary endpoint

•Adverse events

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07842640

Org study IDASC35-101

Timeline

Milestones

Study start2026-08-27actual

Study first posted2026-09-25actual

Last update posted2026-09-25actual

Primary completion2027-06estimated (month precision)

Study completion2027-06estimated (month precision)

Assets

Investigational agents

ASC35 Tirzepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight