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CompletedPhase 1

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection, for Subcutaneous Use in Combination With Semaglutide in Participants With Obesity

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

28

actual

Study population

Obesity / overweight

Key I/E criterion

Primary endpoint

Serious AEs (any) (Serious AEs (any), Treatment-emergent AEs (any))

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 IDNCT06972992
Org study IDASC47-103

Timeline

Milestones

Study start2025-04-18actual
Study first posted2025-05-15actual
Primary completion2025-09-22actual
Study completion2025-09-22actual
Last update posted2025-12-18actual

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

Subject have provided informed consent before initiation of any study specific procedures
Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, e.g., Clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia as assessed by the Investigator (or sub-I).
Stable body weight (less than 5% self-reported change within the previous 3 months)

Exclusion criteria

Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.
Have a history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year.
Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 half-lives of the experimental agent (exception of placebo) prior to the start of the treatment.

Endpoints (6)

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
5
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:up to 71 days

Body weight, absolute change (kg)

change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Adverse events

Time frame:up to 71 days

Serious AEs (any)

event count, event

componentsSerious AEs (any), Treatment-emergent AEs (any)

Secondary/protocol endpoint

Cmax of ASC47

Time frame:up to 71 days

Cmax

concentration, descriptive

Secondary/protocol endpoint/low confidence

AUC of ASC47

Time frame:up to 71 days

concentration, descriptive

Secondary/protocol endpoint

T1/2 of ASC47

Time frame:up to 71 days

Half-life

descriptive

Secondary/protocol endpoint

CL/F of ASC47

Time frame:up to 71 days

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.