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

A Phase I/IIa, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Injection, for Subcutaneous Use in Participants With Obesity

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06679959

Enrollment

115

Registered

2024-11-08

Start date

2024-09-16

Completion date

2026-03-26

Last updated

2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Weight Management

Brief 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

Interventions

DRUGASC30 Injection, for subcutaneous use or placebo

Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Have provided informed consent before initiation of any study-specific procedures. 2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive). 3. No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.

Exclusion criteria

1. Have evidence of any clinically significant active or chronic disease. 2. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus. 3. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. 4. Have a history of acute or chronic pancreatitis. 5. Participants with a known clinically significant gastric emptying abnormality. 6. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy. 7. 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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of AEs, SAEs (Safety and tolerability) of ASC30	Up to Day169	A summary of AEs, SAEs and other non-serious adverse events

Secondary

Measure	Time frame	Description
Cmax of ASC30	Up to Day169	PK parameters of ASC30
Change From Baseline in Body Weight	Up to Day169	Change From Baseline in Body Weight

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026