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 | Recruiting Phase 3 FDA Drug

• 1 other identifier: ASC30-301
• Study Type: interventional
• Target: 3,003
• Locations: 7 countries
• Sites: 122

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

Chronic Weight Management; Obesity; Overweight

Keywords

Obesity; Overweight; Weight Management

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight from baseline to Week 72

  Baseline to Week 72

Secondary Outcomes (10)

• 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

Study Arms (4)

ASC30 Cohort 1

EXPERIMENTAL

Participants will receive oral ASC30 tablets A1.

Drug: ASC30 tablets A1

ASC30 Cohort 2

EXPERIMENTAL

Participants will receive oral ASC30 tablets A1.

Drug: ASC30 tablets A1

ASC30 Cohort 3

EXPERIMENTAL

Participants will receive oral ASC30 tablets A1.

Drug: ASC30 tablets A1

Placebo Cohort 4

PLACEBO COMPARATOR

Participants will receive matching placebo tablets orally once daily.

Drug: Placebo

Interventions

ASC30 tablets A1 DRUG

ASC30 tablets A1 administered orally once daily.

ASC30 Cohort 1; ASC30 Cohort 2; ASC30 Cohort 3

Placebo DRUG

Matching placebo tablets administered orally once daily.

Placebo Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascletis Pharma (China) Co., Limited: lead

Study Sites (122)

AURORA-1 Clinical Site

Birmingham, Alabama, 35211-1320, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Huntsville, Alabama, 35802, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Phoenix, Arizona, 85020, United States

RECRUITING

AURORA-1 Clinical Site

Tucson, Arizona, 85741, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Little Rock, Arkansas, 72204, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Banning, California, 92220-3082, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Chula Vista, California, 91910, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Covina, California, 91723-1905, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Gardena, California, 90247-3583, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

La Mesa, California, 91942, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Los Angeles, California, 91405, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Tarzana, California, 91356-3508, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Tustin, California, 92780-7074, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Washington D.C., District of Columbia, 20016, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Boca Raton, Florida, 33434, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Daytona Beach, Florida, 32114, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Jacksonville, Florida, 32205-4785, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Leesburg, Florida, 34748-5077, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Melbourne, Florida, 32934-8172, United States

RECRUITING

AURORA-1 Clinical Site

South Miami, Florida, 33143, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Tampa, Florida, 33613-1244, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

The Villages, Florida, 32162, United States

RECRUITING

AURORA-1 Clinical Site

Winter Park, Florida, 32789-4681, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Canton, Georgia, 30115, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Decatur, Georgia, 30030-3440, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Union City, Georgia, 30291-2085, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Boise, Idaho, 83704, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Schaumburg, Illinois, 60173, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Evansville, Indiana, 47714-7513, United States

RECRUITING

AURORA-1 Clinical Site

Indianapolis, Indiana, 46254, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Valparaiso, Indiana, 46383, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Kansas City, Kansas, 66112, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Baton Rouge, Louisiana, 70809-3416, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Bowie, Maryland, 20715, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Rockville, Maryland, 20854-2931, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Gulfport, Mississippi, 39503-2637, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Jackson, Mississippi, 39206, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Olive Branch, Mississippi, 38654-3514, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

St Louis, Missouri, 63141, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Las Vegas, Nevada, 89113, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

New Windsor, New York, 12553-7754, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Charlotte, North Carolina, 28262, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Greenville, North Carolina, 27834-5051, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Morehead City, North Carolina, 28557, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Raleigh, North Carolina, 27610, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Cincinnati, Ohio, 45246, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Cleveland, Ohio, 44122-4330, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Columbus, Ohio, 43212-3122, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Dayton, Ohio, 45414, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Eugene, Oregon, 97404-3233, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Bluffton, South Carolina, 29910, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Clemson, South Carolina, 29634, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Columbia, South Carolina, 29204, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Gaffney, South Carolina, 29340-4737, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Memphis, Tennessee, 38119-4823, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Austin, Texas, 78744-1645, United States

RECRUITING

AURORA-1 Clinical Site

Brownsville, Texas, 78520, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

DeSoto, Texas, 75115-2043, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Frisco, Texas, 75033-4133, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Mesquite, Texas, 75149, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

San Antonio, Texas, 78229-3272, United States

RECRUITING

AURORA-1 Clinical Site

San Antonio, Texas, 78229-3539, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Sugar Land, Texas, 77478, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Tomball, Texas, 77375, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Weslaco, Texas, 78596-7288, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Wichita Falls, Texas, 76301, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Salt Lake City, Utah, 84124-3543, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Hampton, Virginia, 23666, United States

NOT YET RECRUITING

AURORA-1 Clinical Site

Burlington, L7R 1E2, Canada

NOT YET RECRUITING

AURORA-1 Clinical Site

Pardubice, 530 02, Czechia

NOT YET RECRUITING

AURORA-1 Clinical Site

Prague, 120 00, Czechia

NOT YET RECRUITING

AURORA-1 Clinical Site

Prague, 150 00, Czechia

NOT YET RECRUITING

AURORA-1 Clinical Site

Uherské Hradiště, 686 01, Czechia

NOT YET RECRUITING

AURORA-1 Clinical Site

Berlin, 10629, Germany

NOT YET RECRUITING

AURORA-1 Clinical Site

Berlin, 10787, Germany

NOT YET RECRUITING

AURORA-1 Clinical Site

Essen, 45355, Germany

NOT YET RECRUITING

AURORA-1 Clinical Site

Hanover, 30159, Germany

NOT YET RECRUITING

AURORA-1 Clinical Site

Leipzig, 04107, Germany

NOT YET RECRUITING

AURORA-1 Clinical Site

Athens, 106 76, Greece

NOT YET RECRUITING

AURORA-1 Clinical Site

Athens, 115 27, Greece

NOT YET RECRUITING

AURORA-1 Clinical Site

Athens, 115 28, Greece

NOT YET RECRUITING

AURORA-1 Clinical Site

Larissa, 411 10, Greece

NOT YET RECRUITING

AURORA-1 Clinical Site

Marousi, 151 23, Greece

NOT YET RECRUITING

AURORA-1 Clinical Site

Palaió Fáliro, 175 62, Greece

NOT YET RECRUITING

AURORA-1 Clinical Site

Pylaia, 570 01, Greece

NOT YET RECRUITING

AURORA-1 Clinical Site

Thessaloniki, 546 36, Greece

NOT YET RECRUITING

AURORA-1 Clinical Site

Thessaloniki, 546 42, Greece

NOT YET RECRUITING

AURORA-1 Clinical Site

Biała Podlaska, 21-500, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Bydgoszcz, 85-092, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Częstochowa, 42-202, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Gdansk, 80-382, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Gdynia, 81-384, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Gdynia, 81-537, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Katowice, 40-040, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Krakow, 31-261, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Krakow, 31-501, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Lodz, 90-127, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Lodz, 91-363, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Lublin, 20-011, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Lublin, 20-362, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Poznan, 60-324, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Poznan, 60-702, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Puławy, 24-100, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Siedlce, 08-110, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Staszów, 28-200, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Torun, 87-100, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Warsaw, 00-215, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Warsaw, 00-710, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Warsaw, 01-696, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Warsaw, 02-672, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Warsaw, 03-291, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Wroclaw, 50-381, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Wroclaw, 53-673, Poland

NOT YET RECRUITING

AURORA-1 Clinical Site

Bellshill, ML4 3NJ, United Kingdom

NOT YET RECRUITING

AURORA-1 Clinical Site

Cardiff, CF15 9SS, United Kingdom

NOT YET RECRUITING

AURORA-1 Clinical Site

Edgbaston, B16 8QQ, United Kingdom

NOT YET RECRUITING

AURORA-1 Clinical Site

London, E1 1AG, United Kingdom

NOT YET RECRUITING

AURORA-1 Clinical Site

Manchester, M11 1AA, United Kingdom

NOT YET RECRUITING

AURORA-1 Clinical Site

Manchester, M156SE, United Kingdom

NOT YET RECRUITING

AURORA-1 Clinical Site

Stoke-on-Trent, ST1 5SJ, United Kingdom

NOT YET RECRUITING

AURORA-1 Clinical Site

Warrington, WA1 3TZ, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

US (69); GR (9); PL (26); CA (1); GB (8); DE (5); CZ (4)