AURORA-1
RecruitingPhase 3A 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)
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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:
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
Weight & body composition
3 endpointsPercent change in body weight from baseline to Week 72
Time frame:Baseline to Week 72
percent change from baseline, improvement
Change in waist circumference from baseline
Time frame:Baseline to Week 72
change from baseline, improvement
Change in body mass index (BMI) from baseline (kg/m²)
Time frame:Baseline to Week 72
change from baseline, improvement
Glycemic / diabetes
3 endpointsChange in HbA1c from baseline (%)
Time frame:Baseline to Week 72
change from baseline, improvement
Change in fasting glucose from baseline (mg/dL)
Time frame:Baseline to Week 72
change from baseline, improvement
Change in fasting insulin from baseline (pmol/L)
Time frame:Baseline to Week 72
change from baseline, improvement
Cardiometabolic biomarkers
5 endpointsChange in systolic blood pressure (SBP) from baseline
Time frame:Baseline to Week 72
change from baseline, improvement
Percent change in fasting triglycerides from baseline
Time frame:Baseline to Week 72
percent change from baseline, improvement
Percent change from baseline in fasting non-HDL cholesterol
Time frame:Baseline to Week 72
percent change from baseline, improvement
Change in diastolic blood pressure (DBP) from baseline
Time frame:Baseline to Week 72
change from baseline, improvement
Percent change in fasting total cholesterol from baseline
Time frame:Baseline to Week 72
percent change from baseline, improvement
Provenance
Sources
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.