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
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
3,003
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Lead sponsor
Ascletis Pharma (China) Co., Limited
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Start date
2026-08-01
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Number of sites
120
clinicaltrials.gov

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.
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Acronym
AURORA-1
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Short title
A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
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Official title
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-07-01
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First posted
2026-08-03
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Registry last updated
2026-08-14
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Primary completion date
2028-07-01
clinicaltrials.gov
Start date
2026-08-01
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Participants
3,003
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Participant count basis
Estimated
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Planned participants
3,003
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Protocol amendments
1
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Number of sites
120
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Ascletis Pharma (China) Co., Limited
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07743463
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ClinicalTrials.gov ID
NCT07743463
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent change in body weight from baseline to Week 72

    Timeframe: Baseline to Week 72

  1. Change in waist circumference from baseline

    Timeframe: Baseline to Week 72

  2. Change in systolic blood pressure (SBP) from baseline

    Timeframe: Baseline to Week 72

  3. Percent change in fasting triglycerides from baseline

    Timeframe: Baseline to Week 72

  4. Change in body mass index (BMI) from baseline (kg/m²)

    Timeframe: Baseline to Week 72

  5. Change in HbA1c from baseline (%)

    Timeframe: Baseline to Week 72

  6. Percent change from baseline in fasting non-HDL cholesterol

    Timeframe: Baseline to Week 72

  7. Change in fasting glucose from baseline (mg/dL)

    Timeframe: Baseline to Week 72

  8. Change in fasting insulin from baseline (pmol/L)

    Timeframe: Baseline to Week 72

  9. Change in diastolic blood pressure (DBP) from baseline

    Timeframe: Baseline to Week 72

  10. Percent change in fasting total cholesterol from baseline

    Timeframe: Baseline to Week 72

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
clinicaltrials.gov

  • AURORA-1 Clinical SiteBirmingham, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteHuntsville, United StatesNot yet recruiting
  • AURORA-1 Clinical SitePhoenix, United StatesRecruiting
  • AURORA-1 Clinical SiteTempe, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteTucson, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteLittle Rock, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteBanning, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteChula Vista, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteCovina, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteGardena, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteTarzana, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteTustin, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteWashington D.C., United StatesNot yet recruiting
  • AURORA-1 Clinical SiteBoca Raton, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteDaytona Beach, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteJacksonville, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteLeesburg, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteMelbourne, United StatesRecruiting
  • AURORA-1 Clinical SiteSouth Miami, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteTampa, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteThe Villages, United StatesRecruiting
  • AURORA-1 Clinical SiteWinter Park, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteCanton, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteDecatur, United StatesNot yet recruiting
  • AURORA-1 Clinical SiteUnion City, United StatesNot yet recruiting

And 95 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)