Recruiting
Phase 3

ASC30

Sponsor:

Ascletis Pharma (China) Co., Limited

Code:

NCT07743463

Conditions

Obesity

Overweight

Chronic Weight Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ASC30 tablets A1

Placebo

Study Details

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.

Conditions

Obesity

Overweight

Chronic Weight Management

Study ID

NCT07743463

Start date

Aug, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

3003 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ASC30 Cohort 1

Participants will receive oral ASC30 tablets A1.

experimental: ASC30 Cohort 2

Participants will receive oral ASC30 tablets A1.

experimental: ASC30 Cohort 3

Participants will receive oral ASC30 tablets A1.

placebo comparator: Placebo Cohort 4

Participants will receive matching placebo tablets orally once daily.

Interventions

ASC30 tablets A1

ASC30 tablets A1 administered orally once daily.

Placebo

Matching placebo tablets administered orally once daily.

Primary outcome measure

  • Percent change in body weight from baseline to Week 72 [ Time Frame: Baseline to Week 72 ]

Central Contacts and Locations

Locations

AURORA-1 Clinical Site

Recruiting

Phoenix, Arizona, United States, 85020

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

AURORA-1 Clinical Site

Recruiting

Melbourne, Florida, United States, 32934-8172

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

AURORA-1 Clinical Site

Recruiting

The Villages, Florida, United States, 32162

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

AURORA-1 Clinical Site

Recruiting

Evansville, Indiana, United States, 47714-7513

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

AURORA-1 Clinical Site

Recruiting

Austin, Texas, United States, 78744-1645

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

AURORA-1 Clinical Site

Recruiting

San Antonio, Texas, United States, 78229-3272

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

More Information

Sponsor

Ascletis Pharma (China) Co., Limited

Last update posted

Aug 14, 2026

Last verified

Jul, 2026

Keywords

  • Obesity
  • Overweight
  • Weight Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ascletis Pharma (China) Co., Limited on 2026-08-14.