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
- AURORA-2 Clinical Site · Birmingham, AL 35211-1320More trials in Birmingham
- AURORA-2 Clinical Site · Huntsville, AL 35802More trials in Huntsville
AR
- AURORA-2 Clinical Site · Little Rock, AR 72204More trials in Little Rock
AZ
- AURORA-2 Clinical Site · Peoria, AZ 85382More trials in Peoria
- AURORA-2 Clinical Site · Phoenix, AZ 85020Ascletis Recruiting · Study contact · clinicaltrials@ascletis.comMore trials in Phoenix
- AURORA-2 Clinical Site · Tucson, AZ 85741More trials in Tucson
CA
- AURORA-2 Clinical Site · Banning, CA 92220-3082More trials in Banning
- AURORA-2 Clinical Site · Chula Vista, CA 91910More trials in Chula Vista
- AURORA-2 Clinical Site · Covina, CA 91723-1905More trials in Covina
- AURORA-2 Clinical Site · Gardena, CA 90247-3583More trials in Gardena
- AURORA-2 Clinical Site · La Mesa, CA 91942More trials in La Mesa
- AURORA-2 Clinical Site · Los Angeles, CA 91405More trials in Los Angeles
- AURORA-2 Clinical Site · Sacramento, CA 95821-2640More trials in Sacramento
- AURORA-2 Clinical Site · Tarzana, CA 91356-3508More trials in Tarzana
- AURORA-2 Clinical Site · Tustin, CA 92780-7074More trials in Tustin
DC
- AURORA-2 Clinical Site · Washington D.C., DC 20016More trials in Washington D.C.
FL
- AURORA-2 Clinical Site · Boca Raton, FL 33434More trials in Boca Raton
- AURORA-2 Clinical Site · Daytona Beach, FL 32114More trials in Daytona Beach
- AURORA-2 Clinical Site · Jacksonville, FL 32205-4785More trials in Jacksonville
- AURORA-2 Clinical Site · Leesburg, FL 34748-5077More trials in Leesburg
- AURORA-2 Clinical Site · Melbourne, FL 32934-8172Ascletis Recruiting · Study contact · clinicaltrials@ascletis.comMore trials in Melbourne
- AURORA-2 Clinical Site · South Miami, FL 33143More trials in South Miami
- AURORA-2 Clinical Site · Tampa, FL 33613-1244More trials in Tampa
- AURORA-2 Clinical Site · The Villages, FL 32162Ascletis Recruiting · Study contact · clinicaltrials@ascletis.comMore trials in The Villages
- AURORA-2 Clinical Site · Winter Park, FL 32789-4681More trials in Winter Park
GA
- AURORA-2 Clinical Site · Canton, GA 30115More trials in Canton
- AURORA-2 Clinical Site · Decatur, GA 30030-3440More trials in Decatur
- AURORA-2 Clinical Site · Union City, GA 30291-2085More trials in Union City
ID
- AURORA-2 Clinical Site · Boise, ID 83704More trials in Boise
IL
- AURORA-2 Clinical Site · Schaumburg, IL 60173More trials in Schaumburg
IN
- AURORA-2 Clinical Site · Evansville, IN 47714-7513Ascletis Recruiting · Study contact · clinicaltrials@ascletis.comMore trials in Evansville
- AURORA-2 Clinical Site · Indianapolis, IN 46254More trials in Indianapolis
- AURORA-2 Clinical Site · Valparaiso, IN 46383More trials in Valparaiso
KS
- AURORA-2 Clinical Site · Kansas City, KS 66112More trials in Kansas City
LA
- AURORA-2 Clinical Site · Baton Rouge, LA 70809-3416More trials in Baton Rouge
- AURORA-2 Clinical Site · Metairie, LA 70006More trials in Metairie
MD
- AURORA-2 Clinical Site · Bowie, MD 20715More trials in Bowie
- AURORA-2 Clinical Site · Rockville, MD 20854-2931More trials in Rockville
MI
- AURORA-2 Clinical Site · Southfield, MI 48076-5412More trials in Southfield
MN
- AURORA-2 Clinical Site · Mankato, MN 56001More trials in Mankato
MO
- AURORA-2 Clinical Site · Columbia, MO 65201More trials in Columbia
- AURORA-2 Clinical Site · St Louis, MO 63141More trials in St Louis
MS
- AURORA-2 Clinical Site · Gulfport, MS 39503-2637More trials in Gulfport
- AURORA-2 Clinical Site · Jackson, MS 39206More trials in Jackson
- AURORA-2 Clinical Site · Olive Branch, MS 38654-3514More trials in Olive Branch
NC
- AURORA-2 Clinical Site · Charlotte, NC 28262More trials in Charlotte
- AURORA-2 Clinical Site · Durham, NC 27701More trials in Durham
- AURORA-2 Clinical Site · Greenville, NC 27834-5051More trials in Greenville
- AURORA-2 Clinical Site · Morehead City, NC 28557More trials in Morehead City
- AURORA-2 Clinical Site · Raleigh, NC 27610More trials in Raleigh
NJ
- AURORA-2 Clinical Site · Jersey City, NJ 07306-4004More trials in Jersey City
NV
- AURORA-2 Clinical Site · Las Vegas, NV 89113More trials in Las Vegas
NY
- AURORA-2 Clinical Site · East Northport, NY 11731More trials in East Northport
- AURORA-2 Clinical Site · East Syracuse, NY 13057More trials in East Syracuse
- AURORA-2 Clinical Site · New Windsor, NY 12553-7754More trials in New Windsor
OH
- AURORA-2 Clinical Site · Cincinnati, OH 45246More trials in Cincinnati
- AURORA-2 Clinical Site · Cleveland, OH 44122-4330More trials in Cleveland
- AURORA-2 Clinical Site · Columbus, OH 43212-3122More trials in Columbus
- AURORA-2 Clinical Site · Dayton, OH 45414More trials in Dayton
OK
- AURORA-2 Clinical Site · Oklahoma City, OK 73118-2872More trials in Oklahoma City
OR
- AURORA-2 Clinical Site · Eugene, OR 97404-3233More trials in Eugene
PA
- AURORA-2 Clinical Site · Philadelphia, PA 19107More trials in Philadelphia
- AURORA-2 Clinical Site · Pittsburgh, PA 15243-1800More trials in Pittsburgh
SC
- AURORA-2 Clinical Site · Bluffton, SC 29910More trials in Bluffton
- AURORA-2 Clinical Site · Clemson, SC 29634More trials in Clemson
- AURORA-2 Clinical Site · Columbia, SC 29204More trials in Columbia
- AURORA-2 Clinical Site · Gaffney, SC 29340-4737More trials in Gaffney
TN
- AURORA-2 Clinical Site · Memphis, TN 38119-4823More trials in Memphis
TX
- AURORA-2 Clinical Site · Austin, TX 78744-1645Ascletis Recruiting · Study contact · clinicaltrials@ascletis.comMore trials in Austin
- AURORA-2 Clinical Site · Brownsville, TX 78520More trials in Brownsville
- AURORA-2 Clinical Site · DeSoto, TX 75115-2043More trials in DeSoto
- AURORA-2 Clinical Site · Frisco, TX 75033-4133More trials in Frisco
- AURORA-2 Clinical Site · Houston, TX 77024More trials in Houston
- AURORA-2 Clinical Site · Mesquite, TX 75149More trials in Mesquite
- AURORA-2 Clinical Site · San Antonio, TX 78229-3272Ascletis Recruiting · Study contact · clinicaltrials@ascletis.comMore trials in San Antonio
- AURORA-2 Clinical Site · San Antonio, TX 78229-3539More trials in San Antonio
- AURORA-2 Clinical Site · Sugar Land, TX 77478More trials in Sugar Land
- AURORA-2 Clinical Site · Tomball, TX 77375More trials in Tomball
- AURORA-2 Clinical Site · Waxahachie, TX 75165-1430More trials in Waxahachie
- AURORA-2 Clinical Site · Weslaco, TX 78596-7288More trials in Weslaco
- AURORA-2 Clinical Site · Wichita Falls, TX 76301More trials in Wichita Falls
UT
- AURORA-2 Clinical Site · Salt Lake City, UT 84124-3543More trials in Salt Lake City
VA
- AURORA-2 Clinical Site · Hampton, VA 23666More trials in Hampton
WA
- AURORA-2 Clinical Site · Seattle, WA 98122More trials in Seattle