A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
Ascletis Pharma (China) Co., Limited · NCT07743463
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 3003
- US sites recruiting
- 6
- Study start
- August 31, 2026
- Record last updated
- September 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ASC30 tablets A1; Placebo
Conditions: Obesity; Overweight; Chronic Weight Management
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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 2.
- 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.
Recruiting US locations
AURORA-1 Clinical Site
Phoenix, AZ 85020
Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com
AURORA-1 Clinical Site
Melbourne, FL 32934-8172
Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com
AURORA-1 Clinical Site
The Villages, FL 32162
Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com
AURORA-1 Clinical Site
Evansville, IN 47714-7513
Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com
AURORA-1 Clinical Site
Austin, TX 78744-1645
Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com
AURORA-1 Clinical Site
San Antonio, TX 78229-3272
Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com
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