Clinical trial

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

Recruiting now · Phase 3 · 5 countries · Registry ID NCT07743463

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight, Chronic Weight Management

Full registry criteria

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.

Treatments and study arms

ASC30 tablets A1

Drug

ASC30 tablets A1 administered orally once daily.

Placebo

Drug

Matching placebo tablets administered orally once daily.

Primary outcomes

Percent change in body weight from baseline to Week 72Baseline to Week 72

Study locations

120 locations were listed when this page was built. The first 40 are shown.

AURORA-1 Clinical Site🇨🇦 Burlington, Canada
AURORA-1 Clinical Site🇨🇿 Pardubice, Czechia
AURORA-1 Clinical Site🇨🇿 Prague, Czechia
AURORA-1 Clinical Site🇨🇿 Prague, Czechia
AURORA-1 Clinical Site🇨🇿 Uherské Hradiště, Czechia
AURORA-1 Clinical Site🇩🇪 Berlin, Germany
AURORA-1 Clinical Site🇩🇪 Berlin, Germany
AURORA-1 Clinical Site🇩🇪 Essen, Germany
AURORA-1 Clinical Site🇩🇪 Hanover, Germany
AURORA-1 Clinical Site🇩🇪 Leipzig, Germany
AURORA-1 Clinical Site🇬🇷 Athens, Greece
AURORA-1 Clinical Site🇬🇷 Athens, Greece
AURORA-1 Clinical Site🇬🇷 Athens, Greece
AURORA-1 Clinical Site🇬🇷 Larissa, Greece
AURORA-1 Clinical Site🇬🇷 Marousi, Greece
AURORA-1 Clinical Site🇬🇷 Palaió Fáliro, Greece
AURORA-1 Clinical Site🇬🇷 Pylaia, Greece
AURORA-1 Clinical Site🇬🇷 Thessaloniki, Greece
AURORA-1 Clinical Site🇬🇷 Thessaloniki, Greece
AURORA-1 Clinical Site🇵🇱 Biała Podlaska, Poland
AURORA-1 Clinical Site🇵🇱 Bydgoszcz, Poland
AURORA-1 Clinical Site🇵🇱 Częstochowa, Poland
AURORA-1 Clinical Site🇵🇱 Gdansk, Poland
AURORA-1 Clinical Site🇵🇱 Gdynia, Poland
AURORA-1 Clinical Site🇵🇱 Gdynia, Poland
AURORA-1 Clinical Site🇵🇱 Katowice, Poland
AURORA-1 Clinical Site🇵🇱 Krakow, Poland
AURORA-1 Clinical Site🇵🇱 Krakow, Poland
AURORA-1 Clinical Site🇵🇱 Lodz, Poland
AURORA-1 Clinical Site🇵🇱 Lodz, Poland
AURORA-1 Clinical Site🇵🇱 Lublin, Poland
AURORA-1 Clinical Site🇵🇱 Lublin, Poland
AURORA-1 Clinical Site🇵🇱 Poznan, Poland
AURORA-1 Clinical Site🇵🇱 Poznan, Poland
AURORA-1 Clinical Site🇵🇱 Puławy, Poland
AURORA-1 Clinical Site🇵🇱 Siedlce, Poland
AURORA-1 Clinical Site🇵🇱 Staszów, Poland
AURORA-1 Clinical Site🇵🇱 Torun, Poland
AURORA-1 Clinical Site🇵🇱 Warsaw, Poland
AURORA-1 Clinical Site🇵🇱 Warsaw, Poland