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

NCT06680440 | Completed Phase 1 FDA Drug

• 1 other identifier: ASC30-102
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Cmax of ASC30 (SAD)

  Up to Day 8

• Cmax of ASC30 (MAD)

  Up to Day 28

• Change From Baseline in Body Weight (MAD)

  Up to Day 28

Study Arms (8)

SAD Cohort 1

EXPERIMENTAL

SAD dose 1

Drug: ASC30; Other: Placebo

SAD Cohort 2

EXPERIMENTAL

SAD dose 2

Drug: ASC30; Other: Placebo

SAD Cohort 3

EXPERIMENTAL

SAD dose 3

Drug: ASC30; Other: Placebo

SAD Cohort 4

EXPERIMENTAL

SAD dose 4

Drug: ASC30; Other: Placebo

SAD Cohort 5

EXPERIMENTAL

SAD dose 5

Drug: ASC30; Other: Placebo

MAD Cohort 1

EXPERIMENTAL

MAD dose 1

Drug: ASC30; Other: Placebo

MAD Cohort 2

EXPERIMENTAL

MAD dose 2

Drug: ASC30; Other: Placebo

MAD Cohort 3

EXPERIMENTAL

MAD dose 3

Drug: ASC30; Other: Placebo

Interventions

ASC30 DRUG

Tablet, QD

MAD Cohort 1; MAD Cohort 2; MAD Cohort 3; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4; SAD Cohort 5

Placebo OTHER

Tablets, QD

MAD Cohort 1; MAD Cohort 2; MAD Cohort 3; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4; SAD Cohort 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Ascletis clinical site

Salt Lake City, Utah, 84124, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 8, 2024
• Study Start: August 26, 2024
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: May 20, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)