NCT07743463RecruitingPhase 3
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)
Ascletis Pharma (China) Co., Limited125 sites in 1 country3,003 target enrollmentStarted: August 31, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 3,003
- Locations
- 125
- Primary Endpoint
- Percent change in body weight from baseline to Week 72
Study Overview
Brief Summary
Study ASC30-301 (AURORA-1) is a Phase III, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the long-term efficacy, safety, and tolerability of three maintenance doses of once-daily oral ASC30 compared with placebo in participants with obesity or overweight without T2DM.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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).
- •Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Exclusion Criteria
- •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.
- •Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening.
- •Have an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2, as determined by the laboratory at screening.
- •Have a history of acute or chronic pancreatitis any time prior to screening.
- •Have known allergies or intolerance to other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs.
- •Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type
- •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.
Arms & Interventions
ASC30 Cohort 1
Experimental
Participants will receive oral ASC30 tablets A1.
Intervention: ASC30 tablets A1 (Drug)
ASC30 Cohort 2
Experimental
Participants will receive oral ASC30 tablets A1.
Intervention: ASC30 tablets A1 (Drug)
ASC30 Cohort 3
Experimental
Participants will receive oral ASC30 tablets A1.
Intervention: ASC30 tablets A1 (Drug)
Placebo Cohort 4
Placebo Comparator
Participants will receive matching placebo tablets orally once daily.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent change in body weight from baseline to Week 72
Time Frame: Baseline to Week 72
Secondary Outcomes
- Change in fasting insulin from baseline (pmol/L)(Baseline to Week 72)
- Change in diastolic blood pressure (DBP) from baseline(Baseline to Week 72)
- Change in waist circumference from baseline(Baseline to Week 72)
- Change in systolic blood pressure (SBP) from baseline(Baseline to Week 72)
- Percent change in fasting triglycerides from baseline(Baseline to Week 72)
- Change in body mass index (BMI) from baseline (kg/m²)(Baseline to Week 72)
- Change in HbA1c from baseline (%)(Baseline to Week 72)
- Percent change from baseline in fasting non-HDL cholesterol(Baseline to Week 72)
- Change in fasting glucose from baseline (mg/dL)(Baseline to Week 72)
- Percent change in fasting total cholesterol from baseline(Baseline to Week 72)
Investigators
Study Sites (125)
Loading locations...
Similar Trials
Active, not recruiting
Phase 3
A Study of Rilvegostomig Plus Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After ResectionCTRI/2024/02/063127AstraZeneca AB750
Completed
Phase 3
Study to Test the Effectiveness, Safety, and Tolerability of Two Homeopathic Treatments (IMP1 and IMP2) for Hypothyroidism in Adults.CTRI/2025/03/081845Biosimilia Pvt. Ltd60
Not yet recruiting
Phase 3
Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy and Platinum Chemotherapy (DUBLIN-4)Non-Small Cell Lung CancerNCT07361484BeyondSpring Pharmaceuticals Inc.442
Recruiting
Phase 3
A Study of DA-302168S in Participants With Overweight/ObesityNCT07629544Chendu DIAO Pharmaceutical Group CO., LTD.840
Recruiting
Phase 3
A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DMWeight ManagementNCT07667803AstraZeneca4,500