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NCT07743463PHASE3Recruiting

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

Start Date

8/31/2026

Completion Date

7/1/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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 at the investigator's discretion.

Interventions

DRUG

ASC30 tablets A1

DRUG

Placebo

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Conditions

ObesityOverweightChronic Weight Management

Locations

AURORA-1 Clinical Site

Birmingham, Alabama 35211-1320

United States

AURORA-1 Clinical Site

Huntsville, Alabama 35802

United States

AURORA-1 Clinical Site

Phoenix, Arizona 85020

United States

AURORA-1 Clinical Site

Tucson, Arizona 85741

United States

AURORA-1 Clinical Site

Little Rock, Arkansas 72204

United States

AURORA-1 Clinical Site

Banning, California 92220-3082

United States

AURORA-1 Clinical Site

Chula Vista, California 91910

United States

AURORA-1 Clinical Site

Covina, California 91723-1905

United States

AURORA-1 Clinical Site

Gardena, California 90247-3583

United States

AURORA-1 Clinical Site

La Mesa, California 91942

United States

AURORA-1 Clinical Site

Los Angeles, California 91405

United States

AURORA-1 Clinical Site

Tarzana, California 91356-3508

United States

AURORA-1 Clinical Site

Tustin, California 92780-7074

United States

AURORA-1 Clinical Site

Washington D.C., District of Columbia 20016

United States

AURORA-1 Clinical Site

Boca Raton, Florida 33434

United States

AURORA-1 Clinical Site

Daytona Beach, Florida 32114

United States

AURORA-1 Clinical Site

Jacksonville, Florida 32205-4785

United States

AURORA-1 Clinical Site

Leesburg, Florida 34748-5077

United States

AURORA-1 Clinical Site

Melbourne, Florida 32934-8172

United States

AURORA-1 Clinical Site

South Miami, Florida 33143

United States

AURORA-1 Clinical Site

Tampa, Florida 33613-1244

United States

AURORA-1 Clinical Site

The Villages, Florida 32162

United States

AURORA-1 Clinical Site

Winter Park, Florida 32789-4681

United States

AURORA-1 Clinical Site

Canton, Georgia 30115

United States

AURORA-1 Clinical Site

Decatur, Georgia 30030-3440

United States

AURORA-1 Clinical Site

Union City, Georgia 30291-2085

United States

AURORA-1 Clinical Site

Boise, Idaho 83704

United States

AURORA-1 Clinical Site

Schaumburg, Illinois 60173

United States

AURORA-1 Clinical Site

Evansville, Indiana 47714-7513

United States

AURORA-1 Clinical Site

Indianapolis, Indiana 46254

United States

AURORA-1 Clinical Site

Valparaiso, Indiana 46383

United States

AURORA-1 Clinical Site

Kansas City, Kansas 66112

United States

AURORA-1 Clinical Site

Baton Rouge, Louisiana 70809-3416

United States

AURORA-1 Clinical Site

Bowie, Maryland 20715

United States

AURORA-1 Clinical Site

Rockville, Maryland 20854-2931

United States

AURORA-1 Clinical Site

Gulfport, Mississippi 39503-2637

United States

AURORA-1 Clinical Site

Jackson, Mississippi 39206

United States

AURORA-1 Clinical Site

Olive Branch, Mississippi 38654-3514

United States

AURORA-1 Clinical Site

St Louis, Missouri 63141

United States

AURORA-1 Clinical Site

Las Vegas, Nevada 89113

United States

AURORA-1 Clinical Site

New Windsor, New York 12553-7754

United States

AURORA-1 Clinical Site

Charlotte, North Carolina 28262

United States

AURORA-1 Clinical Site

Greenville, North Carolina 27834-5051

United States

AURORA-1 Clinical Site

Morehead City, North Carolina 28557

United States

AURORA-1 Clinical Site

Raleigh, North Carolina 27610

United States

AURORA-1 Clinical Site

Cincinnati, Ohio 45246

United States

AURORA-1 Clinical Site

Cleveland, Ohio 44122-4330

United States

AURORA-1 Clinical Site

Columbus, Ohio 43212-3122

United States

AURORA-1 Clinical Site

Dayton, Ohio 45414

United States

AURORA-1 Clinical Site

Eugene, Oregon 97404-3233

United States

AURORA-1 Clinical Site

Philadelphia, Pennsylvania 19107

United States

AURORA-1 Clinical Site

Bluffton, South Carolina 29910

United States

AURORA-1 Clinical Site

Clemson, South Carolina 29634

United States

AURORA-1 Clinical Site

Columbia, South Carolina 29204

United States

AURORA-1 Clinical Site

Gaffney, South Carolina 29340-4737

United States

AURORA-1 Clinical Site

Memphis, Tennessee 38119-4823

United States

AURORA-1 Clinical Site

Austin, Texas 78744-1645

United States

AURORA-1 Clinical Site

Brownsville, Texas 78520

United States

AURORA-1 Clinical Site

DeSoto, Texas 75115-2043

United States

AURORA-1 Clinical Site

Frisco, Texas 75033-4133

United States

AURORA-1 Clinical Site

Mesquite, Texas 75149

United States

AURORA-1 Clinical Site

San Antonio, Texas 78229-3272

United States

AURORA-1 Clinical Site

San Antonio, Texas 78229-3539

United States

AURORA-1 Clinical Site

Sugar Land, Texas 77478

United States

AURORA-1 Clinical Site

Tomball, Texas 77375

United States

AURORA-1 Clinical Site

Weslaco, Texas 78596-7288

United States

AURORA-1 Clinical Site

Wichita Falls, Texas 76301

United States

AURORA-1 Clinical Site

Salt Lake City, Utah 84124-3543

United States

AURORA-1 Clinical Site

Hampton, Virginia 23666

United States

AURORA-1 Clinical Site

Burlington, L7R 1E2

Canada

AURORA-1 Clinical Site

Pardubice, 530 02

Czechia

AURORA-1 Clinical Site

Prague, 120 00

Czechia

AURORA-1 Clinical Site

Prague, 150 00

Czechia

AURORA-1 Clinical Site

Uherské Hradiště, 686 01

Czechia

AURORA-1 Clinical Site

Berlin, 10629

Germany

AURORA-1 Clinical Site

Berlin, 10787

Germany

AURORA-1 Clinical Site

Essen, 45355

Germany

AURORA-1 Clinical Site

Hanover, 30159

Germany

AURORA-1 Clinical Site

Leipzig, 04107

Germany

AURORA-1 Clinical Site

Athens, 106 76

Greece

AURORA-1 Clinical Site

Athens, 115 27

Greece

AURORA-1 Clinical Site

Athens, 115 28

Greece

AURORA-1 Clinical Site

Larissa, 411 10

Greece

AURORA-1 Clinical Site

Marousi, 151 23

Greece

AURORA-1 Clinical Site

Palaió Fáliro, 175 62

Greece

AURORA-1 Clinical Site

Pylaia, 570 01

Greece

AURORA-1 Clinical Site

Thessaloniki, 546 36

Greece

AURORA-1 Clinical Site

Thessaloniki, 546 42

Greece

AURORA-1 Clinical Site

Biała Podlaska, 21-500

Poland

AURORA-1 Clinical Site

Bydgoszcz, 85-092

Poland

AURORA-1 Clinical Site

Częstochowa, 42-202

Poland

AURORA-1 Clinical Site

Gdansk, 80-382

Poland

AURORA-1 Clinical Site

Gdynia, 81-384

Poland

AURORA-1 Clinical Site

Gdynia, 81-537

Poland

AURORA-1 Clinical Site

Katowice, 40-040

Poland

AURORA-1 Clinical Site

Krakow, 31-261

Poland

AURORA-1 Clinical Site

Krakow, 31-501

Poland

AURORA-1 Clinical Site

Lodz, 90-127

Poland

AURORA-1 Clinical Site

Lodz, 91-363

Poland

AURORA-1 Clinical Site

Lublin, 20-011

Poland

AURORA-1 Clinical Site

Lublin, 20-362

Poland

AURORA-1 Clinical Site

Poznan, 60-324

Poland

AURORA-1 Clinical Site

Poznan, 60-702

Poland

AURORA-1 Clinical Site

Puławy, 24-100

Poland

AURORA-1 Clinical Site

Siedlce, 08-110

Poland

AURORA-1 Clinical Site

Staszów, 28-200

Poland

AURORA-1 Clinical Site

Torun, 87-100

Poland

AURORA-1 Clinical Site

Warsaw, 00-215

Poland

AURORA-1 Clinical Site

Warsaw, 00-710

Poland

AURORA-1 Clinical Site

Warsaw, 01-696

Poland

AURORA-1 Clinical Site

Warsaw, 02-672

Poland

AURORA-1 Clinical Site

Warsaw, 03-291

Poland

AURORA-1 Clinical Site

Wroclaw, 50-381

Poland

AURORA-1 Clinical Site

Wroclaw, 53-673

Poland

AURORA-1 Clinical Site

Bellshill, ML4 3NJ

United Kingdom

AURORA-1 Clinical Site

Cardiff, CF15 9SS

United Kingdom

AURORA-1 Clinical Site

Edgbaston, B16 8QQ

United Kingdom

AURORA-1 Clinical Site

London, E1 1AG

United Kingdom

AURORA-1 Clinical Site

Manchester, M11 1AA

United Kingdom

AURORA-1 Clinical Site

Manchester, M156SE

United Kingdom

AURORA-1 Clinical Site

Stoke-on-Trent, ST1 5SJ

United Kingdom

AURORA-1 Clinical Site

Warrington, WA1 3TZ

United Kingdom