A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes

Recruiting · NCT07743450 · Interventional (participants receive a specific treatment) · Lead sponsor: Ascletis Pharma (China) Co., Limited

View the official record on ClinicalTrials.gov →

Type 2 diabetes Obesity

Interventions studied

ASC30 tablets A1Placebo

What this trial is about

Study ASC30-302 (AURORA-2) 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 and T2DM.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.
Have a BMI ≥ 27 kg/m2 at screening.
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Have a diagnosis of T2D according to the WHO classification or other locally applicable standards, with HbA1c \> 6.5% (48 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.

Exclusion criteria

Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
Have a self-reported change in body weight \>5 kg (11 pounds) within 3 months prior to screening.
Have an estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73 m2, as determined by the laboratory at screening.
Have a history of acute or chronic pancreatitis any time prior to screening.
Have known allergies or intolerance to glucagon-like peptide-1 Receptor Agonists (GLP-1 RA).
Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
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.

Where it is running

60 locations listed across 31 US states.

AURORA-2 Clinical Site - Birmingham, Alabama, United States
AURORA-2 Clinical Site - Huntsville, Alabama, United States
AURORA-2 Clinical Site - Peoria, Arizona, United States
AURORA-2 Clinical Site - Phoenix, Arizona, United States
AURORA-2 Clinical Site - Tucson, Arizona, United States
AURORA-2 Clinical Site - Little Rock, Arkansas, United States
AURORA-2 Clinical Site - Banning, California, United States
AURORA-2 Clinical Site - Chula Vista, California, United States
AURORA-2 Clinical Site - Covina, California, United States
AURORA-2 Clinical Site - Gardena, California, United States
AURORA-2 Clinical Site - La Mesa, California, United States
AURORA-2 Clinical Site - Los Angeles, California, United States
AURORA-2 Clinical Site - Sacramento, California, United States
AURORA-2 Clinical Site - Tarzana, California, United States
AURORA-2 Clinical Site - Tustin, California, United States
AURORA-2 Clinical Site - Washington D.C., District of Columbia, United States
AURORA-2 Clinical Site - Boca Raton, Florida, United States
AURORA-2 Clinical Site - Daytona Beach, Florida, United States
AURORA-2 Clinical Site - Jacksonville, Florida, United States
AURORA-2 Clinical Site - Leesburg, Florida, United States
AURORA-2 Clinical Site - Melbourne, Florida, United States
AURORA-2 Clinical Site - South Miami, Florida, United States
AURORA-2 Clinical Site - Tampa, Florida, United States
AURORA-2 Clinical Site - The Villages, Florida, United States
AURORA-2 Clinical Site - Winter Park, Florida, United States
AURORA-2 Clinical Site - Canton, Georgia, United States
AURORA-2 Clinical Site - Decatur, Georgia, United States
AURORA-2 Clinical Site - Union City, Georgia, United States
AURORA-2 Clinical Site - Boise, Idaho, United States
AURORA-2 Clinical Site - Schaumburg, Illinois, United States
AURORA-2 Clinical Site - Evansville, Indiana, United States
AURORA-2 Clinical Site - Indianapolis, Indiana, United States
AURORA-2 Clinical Site - Valparaiso, Indiana, United States
AURORA-2 Clinical Site - Kansas City, Kansas, United States
AURORA-2 Clinical Site - Baton Rouge, Louisiana, United States
AURORA-2 Clinical Site - Metairie, Louisiana, United States
AURORA-2 Clinical Site - Bowie, Maryland, United States
AURORA-2 Clinical Site - Rockville, Maryland, United States
AURORA-2 Clinical Site - Southfield, Michigan, United States
AURORA-2 Clinical Site - Mankato, Minnesota, United States
AURORA-2 Clinical Site - Gulfport, Mississippi, United States
AURORA-2 Clinical Site - Jackson, Mississippi, United States
AURORA-2 Clinical Site - Olive Branch, Mississippi, United States
AURORA-2 Clinical Site - Columbia, Missouri, United States
AURORA-2 Clinical Site - St Louis, Missouri, United States
AURORA-2 Clinical Site - Las Vegas, Nevada, United States
AURORA-2 Clinical Site - Jersey City, New Jersey, United States
AURORA-2 Clinical Site - East Northport, New York, United States
AURORA-2 Clinical Site - East Syracuse, New York, United States
AURORA-2 Clinical Site - New Windsor, New York, United States
AURORA-2 Clinical Site - Charlotte, North Carolina, United States
AURORA-2 Clinical Site - Durham, North Carolina, United States
AURORA-2 Clinical Site - Greenville, North Carolina, United States
AURORA-2 Clinical Site - Morehead City, North Carolina, United States
AURORA-2 Clinical Site - Raleigh, North Carolina, United States
AURORA-2 Clinical Site - Cincinnati, Ohio, United States
AURORA-2 Clinical Site - Cleveland, Ohio, United States
AURORA-2 Clinical Site - Columbus, Ohio, United States
AURORA-2 Clinical Site - Dayton, Ohio, United States
AURORA-2 Clinical Site - Oklahoma City, Oklahoma, United States

Showing 60 of 135 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →