AURORA-2
RecruitingPhase 3A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes
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 Type 2 Diabetes Mellitus (AURORA-2)
Lead sponsor
Asset
ASC30
Oral · GLP-1 agonist
Listed sites
135
Recruiting sites
6
Estimated enrollment
1,560
Study population
Obesity / overweight, Type 2 diabetes
Eligibility highlights
•BMI ≥27•HbA1c ≥6.5%
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 ≥ 27 kg/m2 at screening.
3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
4. Have a diagnosis of T2D according to the WHO classification or other locally applicable standards, with HbA1c > 6.5% (48 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.
Exclusion criteria
1. Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
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 glucagon-like peptide-1 Receptor Agonists (GLP-1 RA).
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 from baseline in body weight
Time frame:Baseline to Week 72
percent change from baseline, improvement
Change from baseline in BMI (kg/m²)
Time frame:Baseline to Week 72
change from baseline, improvement
Change from baseline in waist circumference (cm)
Time frame:Baseline to Week 72
change from baseline, improvement
Glycemic / diabetes
3 endpointsChange from baseline in HbA1c (%)
Time frame:Baseline to Week 72
change from baseline, improvement
Change from baseline in fasting serum glucose (mg/dL)
Time frame:Baseline to Week 72
change from baseline, improvement
Change from baseline in fasting insulin (pmol/L)
Time frame:Baseline to Week 72
change from baseline, improvement
Cardiometabolic biomarkers
5 endpointsChange from baseline in systolic blood pressure (SBP) (mmHg)
Time frame:Baseline to Week 72
change from baseline, improvement
Percent change from baseline in fasting non-HDL cholesterol
Time frame:Baseline to Week 72
percent change from baseline, improvement
Percent change from baseline in fasting triglycerides
Time frame:Baseline to Week 72
percent change from baseline, improvement
Change from baseline in diastolic blood pressure (DBP) (mmHg)
Time frame:Baseline to Week 72
change from baseline, improvement
Percent change from baseline in fasting total cholesterol
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.