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

Phase 1

Recruiting

• Conditions: Chronic Weight Management
• Interventions: Drug: ASC30 Injection, for subcutaneous use or placebo

• Registration Number: NCT06679959
• Lead Sponsor: Ascletis Pharma (China) Co., Limited

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-16
• Study First Submitted: 2024-10-30
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-08
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SAD Cohort 1	ASC30 Injection, for subcutaneous use or placebo	SAD Dose 1
SAD Cohort 2	ASC30 Injection, for subcutaneous use or placebo	SAD Dose 2
SAD Cohort 3	ASC30 Injection, for subcutaneous use or placebo	SAD Dose 3
SAD Cohort 4	ASC30 Injection, for subcutaneous use or placebo	SAD Dose 4
SAD Cohort 5	ASC30 Injection, for subcutaneous use or placebo	SAD Dose 5
SAD Cohort 6	ASC30 Injection, for subcutaneous use or placebo	SAD Dose 6
SAD Cohort 7	ASC30 Injection, for subcutaneous use or placebo	SAD Dose 7
SAD Cohort 8	ASC30 Injection, for subcutaneous use or placebo	SAD Dose 8
MAD Cohort 1	ASC30 Injection, for subcutaneous use or placebo	MAD Dose 1
MAD Cohort 2	ASC30 Injection, for subcutaneous use or placebo	MAD Dose 2
MAD Cohort 3	ASC30 Injection, for subcutaneous use or placebo	MAD Dose 3

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ascletis clinical site; 🇺🇸 San Antonio, Texas, United States