Active — Not RecruitingPhase 1/2

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASC30 Injection in Participants With Obesity

United States115 participantsStarted 2024-09-16

Plain-language summary

This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASC30 injection

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Have provided informed consent before initiation of any study-specific procedures.
✓. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
✓. 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), or rare forms of diabetes mellitus.
✕. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
✕. Have a history of acute or chronic pancreatitis.
✕. Participants with 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 they're measuring

Incidence of AEs, SAEs (Safety and tolerability) of ASC30

Timeframe: Up to Day169

Trial details

NCT IDNCT06679959

SponsorAscletis Pharma (China) Co., Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04

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