> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-once-daily-oral-asc30-to-evaluate-the-efficacy-4eb8987b-754f-4f29-a68e-ce8bc3c2fe60 > Record changed: 2026-10-13 # A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities NCT07743463 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) Participants 3,003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) Lead sponsor Ascletis Pharma (China) Co., Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) Start date 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) Number of sites 120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Acronym** AURORA-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Short title** A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Dates **Completion date** 2028-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **First posted** 2026-08-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Registry last updated** 2026-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Primary completion date** 2028-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Start date** 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Size and sites **Participants** 3,003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Planned participants** 3,003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Number of sites** 120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Lead sponsor** Ascletis Pharma (China) Co., Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Identifiers **Registry ID** NCT07743463 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **ClinicalTrials.gov ID** NCT07743463 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Outcomes ### Primary outcomes 1. Percent change in body weight from baseline to Week 72 Timeframe: Baseline to Week 72 ### Secondary outcomes 1. Change in waist circumference from baseline Timeframe: Baseline to Week 72 2. Change in systolic blood pressure (SBP) from baseline Timeframe: Baseline to Week 72 3. Percent change in fasting triglycerides from baseline Timeframe: Baseline to Week 72 4. Change in body mass index (BMI) from baseline (kg/m²) Timeframe: Baseline to Week 72 5. Change in HbA1c from baseline (%) Timeframe: Baseline to Week 72 6. Percent change from baseline in fasting non-HDL cholesterol Timeframe: Baseline to Week 72 7. Change in fasting glucose from baseline (mg/dL) Timeframe: Baseline to Week 72 8. Change in fasting insulin from baseline (pmol/L) Timeframe: Baseline to Week 72 9. Change in diastolic blood pressure (DBP) from baseline Timeframe: Baseline to Week 72 10. Percent change in fasting total cholesterol from baseline Timeframe: Baseline to Week 72 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Sites - AURORA-1 Clinical SiteBirmingham, United StatesNot yet recruiting - AURORA-1 Clinical SiteHuntsville, United StatesNot yet recruiting - AURORA-1 Clinical SitePhoenix, United StatesRecruiting - AURORA-1 Clinical SiteTempe, United StatesNot yet recruiting - AURORA-1 Clinical SiteTucson, United StatesNot yet recruiting - AURORA-1 Clinical SiteLittle Rock, United StatesNot yet recruiting - AURORA-1 Clinical SiteBanning, United StatesNot yet recruiting - AURORA-1 Clinical SiteChula Vista, United StatesNot yet recruiting - AURORA-1 Clinical SiteCovina, United StatesNot yet recruiting - AURORA-1 Clinical SiteGardena, United StatesNot yet recruiting - AURORA-1 Clinical SiteTarzana, United StatesNot yet recruiting - AURORA-1 Clinical SiteTustin, United StatesNot yet recruiting - AURORA-1 Clinical SiteWashington D.C., United StatesNot yet recruiting - AURORA-1 Clinical SiteBoca Raton, United StatesNot yet recruiting - AURORA-1 Clinical SiteDaytona Beach, United StatesNot yet recruiting - AURORA-1 Clinical SiteJacksonville, United StatesNot yet recruiting - AURORA-1 Clinical SiteLeesburg, United StatesNot yet recruiting - AURORA-1 Clinical SiteMelbourne, United StatesRecruiting - AURORA-1 Clinical SiteSouth Miami, United StatesNot yet recruiting - AURORA-1 Clinical SiteTampa, United StatesNot yet recruiting - AURORA-1 Clinical SiteThe Villages, United StatesRecruiting - AURORA-1 Clinical SiteWinter Park, United StatesNot yet recruiting - AURORA-1 Clinical SiteCanton, United StatesNot yet recruiting - AURORA-1 Clinical SiteDecatur, United StatesNot yet recruiting - AURORA-1 Clinical SiteUnion City, United StatesNot yet recruiting And 95 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07743463) ## Related records ### Drugs (1) - [Medroxyprogesterone acetate](https://trialight.com/data/asset/medroxyprogesterone-acetate-5514a525-6952-4a47-8871-8a2425a74366.md) ### Lead sponsors (1) - [Ascletis Pharma (China) Co., Limited](https://trialight.com/data/company/ascletis-pharma-china-co-limited-a8ea98f4-0e8f-4bf8-9f74-6e7635b2bfcd.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition ### Targets (1) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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