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

RecruitingPhase 3

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)

Who can join

Ages 18 and older · All sexes

Full eligibility 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 at the investigator's discretion.

About the study

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.

What is being tested

Sponsor: Ascletis Pharma (China) Co., Limited · Participants: 3,003 · Started: Aug 31, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07743463

Locations in the U.S.

AlabamaAURORA-1 Clinical Site, Birmingham (Not yet recruiting)
AURORA-1 Clinical Site, Huntsville (Not yet recruiting)
ArizonaAURORA-1 Clinical Site, Phoenix
AURORA-1 Clinical Site, Tucson (Not yet recruiting)
ArkansasAURORA-1 Clinical Site, Little Rock (Not yet recruiting)
CaliforniaAURORA-1 Clinical Site, Banning (Not yet recruiting)
AURORA-1 Clinical Site, Chula Vista (Not yet recruiting)
AURORA-1 Clinical Site, Covina (Not yet recruiting)
AURORA-1 Clinical Site, Gardena (Not yet recruiting)
AURORA-1 Clinical Site, La Mesa (Not yet recruiting)
AURORA-1 Clinical Site, Los Angeles (Not yet recruiting)
AURORA-1 Clinical Site, Tarzana (Not yet recruiting)
AURORA-1 Clinical Site, Tustin (Not yet recruiting)
District of ColumbiaAURORA-1 Clinical Site, Washington D.C. (Not yet recruiting)
FloridaAURORA-1 Clinical Site, Boca Raton (Not yet recruiting)
AURORA-1 Clinical Site, Daytona Beach (Not yet recruiting)
AURORA-1 Clinical Site, Jacksonville (Not yet recruiting)
AURORA-1 Clinical Site, Leesburg (Not yet recruiting)
AURORA-1 Clinical Site, Melbourne
AURORA-1 Clinical Site, South Miami (Not yet recruiting)
AURORA-1 Clinical Site, Tampa (Not yet recruiting)
AURORA-1 Clinical Site, The Villages
AURORA-1 Clinical Site, Winter Park (Not yet recruiting)
GeorgiaAURORA-1 Clinical Site, Canton (Not yet recruiting)
AURORA-1 Clinical Site, Decatur (Not yet recruiting)
AURORA-1 Clinical Site, Union City (Not yet recruiting)
IdahoAURORA-1 Clinical Site, Boise (Not yet recruiting)
IllinoisAURORA-1 Clinical Site, Schaumburg (Not yet recruiting)
IndianaAURORA-1 Clinical Site, Evansville
AURORA-1 Clinical Site, Indianapolis (Not yet recruiting)
AURORA-1 Clinical Site, Valparaiso (Not yet recruiting)
KansasAURORA-1 Clinical Site, Kansas City (Not yet recruiting)
LouisianaAURORA-1 Clinical Site, Baton Rouge (Not yet recruiting)
MarylandAURORA-1 Clinical Site, Bowie (Not yet recruiting)
AURORA-1 Clinical Site, Rockville (Not yet recruiting)
MississippiAURORA-1 Clinical Site, Gulfport (Not yet recruiting)
AURORA-1 Clinical Site, Jackson (Not yet recruiting)
AURORA-1 Clinical Site, Olive Branch (Not yet recruiting)
MissouriAURORA-1 Clinical Site, St Louis (Not yet recruiting)
NevadaAURORA-1 Clinical Site, Las Vegas (Not yet recruiting)
New YorkAURORA-1 Clinical Site, New Windsor (Not yet recruiting)
North CarolinaAURORA-1 Clinical Site, Charlotte (Not yet recruiting)
AURORA-1 Clinical Site, Greenville (Not yet recruiting)
AURORA-1 Clinical Site, Morehead City (Not yet recruiting)
AURORA-1 Clinical Site, Raleigh (Not yet recruiting)
OhioAURORA-1 Clinical Site, Cincinnati (Not yet recruiting)
AURORA-1 Clinical Site, Cleveland (Not yet recruiting)
AURORA-1 Clinical Site, Columbus (Not yet recruiting)
AURORA-1 Clinical Site, Dayton (Not yet recruiting)
OregonAURORA-1 Clinical Site, Eugene (Not yet recruiting)
PennsylvaniaAURORA-1 Clinical Site, Philadelphia (Not yet recruiting)
South CarolinaAURORA-1 Clinical Site, Bluffton (Not yet recruiting)
AURORA-1 Clinical Site, Clemson (Not yet recruiting)
AURORA-1 Clinical Site, Columbia (Not yet recruiting)
AURORA-1 Clinical Site, Gaffney (Not yet recruiting)
TennesseeAURORA-1 Clinical Site, Memphis (Not yet recruiting)
TexasAURORA-1 Clinical Site, Austin
AURORA-1 Clinical Site, Brownsville (Not yet recruiting)
AURORA-1 Clinical Site, DeSoto (Not yet recruiting)
AURORA-1 Clinical Site, Frisco (Not yet recruiting)
AURORA-1 Clinical Site, Mesquite (Not yet recruiting)
AURORA-1 Clinical Site, San Antonio
AURORA-1 Clinical Site, San Antonio (Not yet recruiting)
AURORA-1 Clinical Site, Sugar Land (Not yet recruiting)
AURORA-1 Clinical Site, Tomball (Not yet recruiting)
AURORA-1 Clinical Site, Weslaco (Not yet recruiting)
AURORA-1 Clinical Site, Wichita Falls (Not yet recruiting)
UtahAURORA-1 Clinical Site, Salt Lake City (Not yet recruiting)
VirginiaAURORA-1 Clinical Site, Hampton (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.