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

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

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.

Study Overview

• Status: Completed
• Conditions: Weight Management
• Intervention / Treatment: Drug: ASC30; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Ascletis Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD Cohort 1; SAD dose 1	Drug: ASC30; Tablet, QD; Other: Placebo; Tablets, QD
Experimental: SAD Cohort 2; SAD dose 2	Drug: ASC30; Tablet, QD; Other: Placebo; Tablets, QD
Experimental: SAD Cohort 3; SAD dose 3	Drug: ASC30; Tablet, QD; Other: Placebo; Tablets, QD
Experimental: SAD Cohort 4; SAD dose 4	Drug: ASC30; Tablet, QD; Other: Placebo; Tablets, QD
Experimental: SAD Cohort 5; SAD dose 5	Drug: ASC30; Tablet, QD; Other: Placebo; Tablets, QD
Experimental: MAD Cohort 1; MAD dose 1	Drug: ASC30; Tablet, QD; Other: Placebo; Tablets, QD
Experimental: MAD Cohort 2; MAD dose 2	Drug: ASC30; Tablet, QD; Other: Placebo; Tablets, QD
Experimental: MAD Cohort 3; MAD dose 3	Drug: ASC30; Tablet, QD; Other: Placebo; Tablets, QD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of ASC30 (SAD)	PK parameters of ASC30	Up to Day 8
Cmax of ASC30 (MAD)	PK parameters of ASC30	Up to Day 28
Change From Baseline in Body Weight (MAD)	Change From Baseline in Body Weight	Up to Day 28

Collaborators and Investigators

• Sponsor: Ascletis Pharma (China) Co., Limited

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Actual): April 3, 2025
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: ASC30-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No