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

NCT ID: NCT06680440

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-26

Study Completion Date

2025-04-03

Brief Summary

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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

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Conditions

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Weight Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SAD Cohort 1

SAD dose 1

Group Type EXPERIMENTAL

ASC30

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablets, QD

SAD Cohort 2

SAD dose 2

Group Type EXPERIMENTAL

ASC30

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablets, QD

SAD Cohort 3

SAD dose 3

Group Type EXPERIMENTAL

ASC30

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablets, QD

SAD Cohort 4

SAD dose 4

Group Type EXPERIMENTAL

ASC30

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablets, QD

SAD Cohort 5

SAD dose 5

Group Type EXPERIMENTAL

ASC30

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablets, QD

MAD Cohort 1

MAD dose 1

Group Type EXPERIMENTAL

ASC30

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablets, QD

MAD Cohort 2

MAD dose 2

Group Type EXPERIMENTAL

ASC30

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablets, QD

MAD Cohort 3

MAD dose 3

Group Type EXPERIMENTAL

ASC30

Intervention Type DRUG

Tablet, QD

Placebo

Intervention Type OTHER

Tablets, QD

Interventions

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ASC30

Tablet, QD

Intervention Type DRUG

Placebo

Tablets, QD

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ascletis Pharma (China) Co., Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ascletis clinical site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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ASC30-102

Identifier Type: -

Identifier Source: org_study_id

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