A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASC30 Tablets and ASC30 Tablets A1 in Participants With Obesity

Phase 1

Completed

• Conditions: Weight Management
• Interventions: Drug: ASC30; Other: Placebo

• Registration Number: NCT06680440
• Lead Sponsor: Ascletis Pharma (China) Co., Limited

Brief Summary

This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of ASC30 Tablets or ASC30 Tablets A1 in participants with obesity.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-26
• Status Verified: 2024-09
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-08
• Primary Completion: 2025-04-03
• Study Completion: 2025-04-03
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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
MAD Cohort 2	Placebo	MAD dose 2
MAD Cohort 3	ASC30	MAD dose 3
MAD Cohort 3	Placebo	MAD dose 3
SAD Cohort 1	ASC30	SAD dose 1
SAD Cohort 5	ASC30	SAD dose 5
SAD Cohort 1	Placebo	SAD dose 1
SAD Cohort 2	ASC30	SAD dose 2
SAD Cohort 2	Placebo	SAD dose 2
SAD Cohort 3	Placebo	SAD dose 3
SAD Cohort 4	ASC30	SAD dose 4
SAD Cohort 3	ASC30	SAD dose 3
MAD Cohort 1	Placebo	MAD dose 1
SAD Cohort 4	Placebo	SAD dose 4
SAD Cohort 5	Placebo	SAD dose 5
MAD Cohort 1	ASC30	MAD dose 1
MAD Cohort 2	ASC30	MAD dose 2

Primary Outcome Measures

Name	Time	Method
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD)	Up to Day 8	A summary of AEs, SAEs and other non-serious adverse events
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (MAD)	Up to Day 28	A summary of AEs, SAEs and other non-serious adverse events

Secondary Outcome Measures

Name	Time	Method
Cmax of ASC30 (SAD)	Up to Day 8	PK parameters of ASC30
Cmax of ASC30 (MAD)	Up to Day 28	PK parameters of ASC30
Change From Baseline in Body Weight (MAD)	Up to Day 28	Change From Baseline in Body Weight

Trial Locations

Locations (1)

Ascletis clinical site; 🇺🇸 Salt Lake City, Utah, United States