A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (AURORA-1)

September 15, 2026 updated by: Ascletis Pharma (China) Co., Limited

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3003

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Burlington, Canada, L7R 1E2
        • Not yet recruiting
        • AURORA-1 Clinical Site
  • Czechia
      • Pardubice, Czechia, 530 02
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Prague, Czechia, 120 00
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Prague, Czechia, 150 00
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Uherské Hradiště, Czechia, 686 01
        • Not yet recruiting
        • AURORA-1 Clinical Site
  • Germany
      • Berlin, Germany, 10629
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Berlin, Germany, 10787
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Essen, Germany, 45355
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Hanover, Germany, 30159
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Leipzig, Germany, 04107
        • Not yet recruiting
        • AURORA-1 Clinical Site
  • Greece
      • Athens, Greece, 106 76
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Athens, Greece, 115 27
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Athens, Greece, 115 28
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Larissa, Greece, 411 10
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Marousi, Greece, 151 23
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Palaió Fáliro, Greece, 175 62
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Pylaia, Greece, 570 01
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Thessaloniki, Greece, 546 36
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Thessaloniki, Greece, 546 42
        • Not yet recruiting
        • AURORA-1 Clinical Site
  • Poland
      • Biała Podlaska, Poland, 21-500
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Bydgoszcz, Poland, 85-092
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Częstochowa, Poland, 42-202
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Gdansk, Poland, 80-382
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Gdynia, Poland, 81-384
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Gdynia, Poland, 81-537
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Katowice, Poland, 40-040
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Krakow, Poland, 31-261
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Krakow, Poland, 31-501
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Lodz, Poland, 90-127
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Lodz, Poland, 91-363
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Lublin, Poland, 20-011
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Lublin, Poland, 20-362
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Poznan, Poland, 60-324
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Poznan, Poland, 60-702
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Puławy, Poland, 24-100
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Siedlce, Poland, 08-110
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Staszów, Poland, 28-200
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Torun, Poland, 87-100
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Warsaw, Poland, 00-215
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Warsaw, Poland, 00-710
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Warsaw, Poland, 01-696
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Warsaw, Poland, 02-672
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Warsaw, Poland, 03-291
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Wroclaw, Poland, 50-381
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Wroclaw, Poland, 53-673
        • Not yet recruiting
        • AURORA-1 Clinical Site
  • United Kingdom
      • Bellshill, United Kingdom, ML4 3NJ
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Cardiff, United Kingdom, CF15 9SS
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Edgbaston, United Kingdom, B16 8QQ
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • London, United Kingdom, E1 1AG
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Manchester, United Kingdom, M11 1AA
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Manchester, United Kingdom, M156SE
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Stoke-on-Trent, United Kingdom, ST1 5SJ
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Warrington, United Kingdom, WA1 3TZ
        • Not yet recruiting
        • AURORA-1 Clinical Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211-1320
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Huntsville, Alabama, United States, 35802
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Arizona
      • Phoenix, Arizona, United States, 85020
      • Tucson, Arizona, United States, 85741
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • California
      • Banning, California, United States, 92220-3082
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Chula Vista, California, United States, 91910
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Covina, California, United States, 91723-1905
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Gardena, California, United States, 90247-3583
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • La Mesa, California, United States, 91942
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Los Angeles, California, United States, 91405
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Tarzana, California, United States, 91356-3508
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Tustin, California, United States, 92780-7074
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Daytona Beach, Florida, United States, 32114
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Jacksonville, Florida, United States, 32205-4785
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Leesburg, Florida, United States, 34748-5077
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Melbourne, Florida, United States, 32934-8172
      • South Miami, Florida, United States, 33143
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Tampa, Florida, United States, 33613-1244
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • The Villages, Florida, United States, 32162
      • Winter Park, Florida, United States, 32789-4681
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Georgia
      • Canton, Georgia, United States, 30115
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Decatur, Georgia, United States, 30030-3440
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Union City, Georgia, United States, 30291-2085
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Illinois
      • Schaumburg, Illinois, United States, 60173
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Indiana
      • Evansville, Indiana, United States, 47714-7513
      • Indianapolis, Indiana, United States, 46254
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Valparaiso, Indiana, United States, 46383
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Kansas
      • Kansas City, Kansas, United States, 66112
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809-3416
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Rockville, Maryland, United States, 20854-2931
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Mississippi
      • Gulfport, Mississippi, United States, 39503-2637
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Jackson, Mississippi, United States, 39206
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Olive Branch, Mississippi, United States, 38654-3514
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • New York
      • New Windsor, New York, United States, 12553-7754
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Greenville, North Carolina, United States, 27834-5051
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Morehead City, North Carolina, United States, 28557
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Raleigh, North Carolina, United States, 27610
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Cleveland, Ohio, United States, 44122-4330
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Columbus, Ohio, United States, 43212-3122
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Dayton, Ohio, United States, 45414
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Oregon
      • Eugene, Oregon, United States, 97404-3233
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Clemson, South Carolina, United States, 29634
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Columbia, South Carolina, United States, 29204
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Gaffney, South Carolina, United States, 29340-4737
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119-4823
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Texas
      • Austin, Texas, United States, 78744-1645
      • Brownsville, Texas, United States, 78520
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • DeSoto, Texas, United States, 75115-2043
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Frisco, Texas, United States, 75033-4133
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Mesquite, Texas, United States, 75149
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • San Antonio, Texas, United States, 78229-3272
      • San Antonio, Texas, United States, 78229-3539
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Sugar Land, Texas, United States, 77478
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Tomball, Texas, United States, 77375
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Weslaco, Texas, United States, 78596-7288
        • Not yet recruiting
        • AURORA-1 Clinical Site
      • Wichita Falls, Texas, United States, 76301
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Utah
      • Salt Lake City, Utah, United States, 84124-3543
        • Not yet recruiting
        • AURORA-1 Clinical Site
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Not yet recruiting
        • AURORA-1 Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASC30 Cohort 1
Participants will receive oral ASC30 tablets A1.
Drug: ASC30 tablets A1
ASC30 tablets A1 administered orally once daily.
Experimental: ASC30 Cohort 2
Participants will receive oral ASC30 tablets A1.
Drug: ASC30 tablets A1
ASC30 tablets A1 administered orally once daily.
Experimental: ASC30 Cohort 3
Participants will receive oral ASC30 tablets A1.
Drug: ASC30 tablets A1
ASC30 tablets A1 administered orally once daily.
Placebo Comparator: Placebo Cohort 4
Participants will receive matching placebo tablets orally once daily.
Drug: Placebo
Matching placebo tablets administered orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in body weight from baseline to Week 72
Time Frame: Baseline to Week 72
Baseline to Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in waist circumference from baseline
Time Frame: Baseline to Week 72
Baseline to Week 72
Change in systolic blood pressure (SBP) from baseline
Time Frame: Baseline to Week 72
Baseline to Week 72
Percent change in fasting triglycerides from baseline
Time Frame: Baseline to Week 72
Baseline to Week 72
Change in body mass index (BMI) from baseline (kg/m²)
Time Frame: Baseline to Week 72
Baseline to Week 72
Change in HbA1c from baseline (%)
Time Frame: Baseline to Week 72
Baseline to Week 72
Percent change from baseline in fasting non-HDL cholesterol
Time Frame: Baseline to Week 72
Baseline to Week 72
Change in fasting glucose from baseline (mg/dL)
Time Frame: Baseline to Week 72
Baseline to Week 72
Change in fasting insulin from baseline (pmol/L)
Time Frame: Baseline to Week 72
Baseline to Week 72
Change in diastolic blood pressure (DBP) from baseline
Time Frame: Baseline to Week 72
Baseline to Week 72
Percent change in fasting total cholesterol from baseline
Time Frame: Baseline to Week 72
Baseline to Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascletis Pharma (China) Co., Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

July 29, 2026

First Submitted That Met QC Criteria

July 29, 2026

First Posted (Actual)

August 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC30-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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