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Active not recruitingPhase 1, PHASE2

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

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

Asset

ASC30

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

115

estimated

Study population

Obesity / overweight

Key I/E criterion

Primary endpoint

AEs, SAEs of ASC30

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06679959
Org study IDASC30-101

Timeline

Milestones

Study start2024-09-16actual
Study first posted2024-11-08actual
Last update posted2025-12-15actual
Primary completion2026-04estimated (month precision)
Study completion2026-04estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Up to Day169

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Incidence of AEs, SAEs (Safety and tolerability) of ASC30

Time frame:Up to Day169

event count, event

Secondary/protocol endpoint

Cmax of ASC30

Time frame:Up to Day169

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.