RecruitingPhase 3

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

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 Type 2 Diabetes Mellitus (AURORA-2)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well three doses of ASC30 work over time and how safe they are compared with a placebo (a pill with no active drug). ASC30 is taken by mouth once a day. The study is for adults with obesity or overweight who also have type 2 diabetes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old, or the legal age to agree to join a study where you live.
  • Have a BMI of 27 or higher at screening. BMI is a measure based on height and weight.
  • Have tried at least once to lose weight through diet without success.
  • Have type 2 diabetes and an HbA1c above 6.5% and no higher than 10.5% at screening. HbA1c measures average blood sugar over time.

Who can't join

  • Have any type of diabetes other than type 2, or a history of ketoacidosis (dangerous acid buildup in the blood) or a hyperosmolar state or coma (a severe high-blood-sugar problem).
  • Have gained or lost more than 11 pounds (5 kg) in the 3 months before screening.
  • Have an eGFR below 15 at screening. This blood test result means the kidneys are working very poorly.
  • Have ever had pancreatitis, which is swelling of the pancreas.
  • Have a known allergy to, or cannot tolerate, GLP-1 receptor agonists, a type of medicine.
  • You or a parent, sibling, or child have had medullary thyroid cancer or MEN type 2, a condition linked to tumors in hormone-making glands.
  • Are in another study testing an experimental treatment, or other medical research that the study doctor thinks cannot be safely or properly combined with this study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 ≥ 27 kg/m2 at screening. 3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. 4. 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: 1. Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM. 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 glucagon-like peptide-1 Receptor Agonists (GLP-1 RA). 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 sites (84)

AL

AR

AZ

CA

DC

FL

GA

ID

IL

IN

KS

LA

MD

MI

MN

MO

MS

NC

NJ

NV

NY

OH

OK

OR

PA

SC

TN

TX

UT

VA

WA