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AURORA-1

RecruitingPhase 3

A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily Oral ASC30 in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (AURORA-1)

Asset

ASC30

Oral · GLP-1 agonist

Listed sites

122

Recruiting sites

6

Estimated enrollment

3,003

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoint

•Body weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07743463
Org study IDASC30-301

Timeline

Milestones

Study first posted2026-08-03actual
Study start2026-08-31actual
Last update posted2026-09-16actual
Primary completion2028-07estimated (month precision)
Study completion2028-07estimated (month precision)

Assets

Investigational agents

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Participant must be ≥18 years of age inclusive, or the legal age of consent in the jurisdiction in which the study is taking place at screening.

2. Have a BMI ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:

-Hypertension
-Dyslipidemia
-Obstructive sleep apnea
-Cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).

3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

1. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma. Participants with a history of gestational diabetes are eligible to participate in this trial.

2. Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening.

3. Have an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2, as determined by the laboratory at screening.

4. Have a history of acute or chronic pancreatitis any time prior to screening.

5. Have known allergies or intolerance to other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs.

6. Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.

7. Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study at the investigator's discretion.

Endpoints (11)

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

Cardiometabolic biomarkers
5
Weight & body composition
3
Glycemic / diabetes
3

Weight & body composition

3 endpoints
Primary/protocol endpoint

Percent change in body weight from baseline to Week 72

Time frame:Baseline to Week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference from baseline

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI) from baseline (kg/m²)

Time frame:Baseline to Week 72

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change in HbA1c from baseline (%)

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting glucose from baseline (mg/dL)

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting insulin from baseline (pmol/L)

Time frame:Baseline to Week 72

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints
Secondary/protocol endpoint

Change in systolic blood pressure (SBP) from baseline

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Percent change in fasting triglycerides from baseline

Time frame:Baseline to Week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in fasting non-HDL cholesterol

Time frame:Baseline to Week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Change in diastolic blood pressure (DBP) from baseline

Time frame:Baseline to Week 72

change from baseline, improvement

Secondary/protocol endpoint

Percent change in fasting total cholesterol from baseline

Time frame:Baseline to Week 72

percent change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.