ClinicalTrials.gg
RecruitingNCT07743450AURORA-2Updated Sep 16, 2026

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 3 interventional study of ASC30 tablets A1 and Placebo in Obesity, Overweight and Chronic Weight Management, sponsored by Ascletis Pharma (China) Co., Limited. Recruiting at 135 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Ascletis Pharma (China) Co., Limited (part of Ascletis Pharma Inc.) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
1,560
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obesity
  • Overweight
  • Chronic Weight Management
  • Type 2 Diabetes Mellitus

Keywords

  • Obesity
  • Overweight
  • Type 2 Diabetes
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 1,560 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Ascletis Pharma (China) Co., Limited is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ≥ 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 > 6.5% (48 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.

Exclusion criteria

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 (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 product or any other type of medical research judged not to be scientifically or medically compatible with this study at the investigator's discretion.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,560 participants (estimated)

Study arms

  • Experimental
    ASC30 Cohort 1

    Participants will receive oral ASC30 tablets A1.

    Drug: ASC30 tablets A1

  • Experimental
    ASC30 Cohort 2

    Participants will receive oral ASC30 tablets A1.

    Drug: ASC30 tablets A1

  • Experimental
    ASC30 Cohort 3

    Participants will receive oral ASC30 tabletsA1.

    Drug: ASC30 tablets A1

  • Placebo comparator
    Placebo Cohort 4

    Participants will receive matching placebo tablets orally once daily.

    Drug: Placebo

Interventions

  • ASC30 tablets A1 administered orally once daily.

  • DrugPlacebo

    Matching placebo tablets administered orally once daily.

06

What researchers measure

Primary outcomes

  1. Percent change from baseline in body weight

    Time frame: Baseline to Week 72

Secondary outcomes

  1. Change from baseline in HbA1c (%)

    Time frame: Baseline to Week 72

  2. Change from baseline in fasting serum glucose (mg/dL)

    Time frame: Baseline to Week 72

  3. Change from baseline in systolic blood pressure (SBP) (mmHg)

    Time frame: Baseline to Week 72

  4. Percent change from baseline in fasting non-HDL cholesterol

    Time frame: Baseline to Week 72

  5. Percent change from baseline in fasting triglycerides

    Time frame: Baseline to Week 72

  6. Change from baseline in BMI (kg/m²)

    Time frame: Baseline to Week 72

  7. Change from baseline in fasting insulin (pmol/L)

    Time frame: Baseline to Week 72

  8. Change from baseline in waist circumference (cm)

    Time frame: Baseline to Week 72

  9. Change from baseline in diastolic blood pressure (DBP) (mmHg)

    Time frame: Baseline to Week 72

  10. Percent change from baseline in fasting total cholesterol

    Time frame: Baseline to Week 72

07

Study locations

6 of 135 sites recruiting
  • AURORA-2 Clinical Site
    Birmingham, Alabama 35211-1320, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Huntsville, Alabama 35802, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Peoria, Arizona 85382, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Phoenix, Arizona 85020, United States
    Recruiting
  • AURORA-2 Clinical Site
    Tucson, Arizona 85741, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Little Rock, Arkansas 72204, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Banning, California 92220-3082, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Chula Vista, California 91910, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Covina, California 91723-1905, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Gardena, California 90247-3583, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    La Mesa, California 91942, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Los Angeles, California 91405, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Sacramento, California 95821-2640, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Tarzana, California 91356-3508, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Tustin, California 92780-7074, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Washington D.C., District of Columbia 20016, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Boca Raton, Florida 33434, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Daytona Beach, Florida 32114, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Jacksonville, Florida 32205-4785, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Leesburg, Florida 34748-5077, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Melbourne, Florida 32934-8172, United States
    Recruiting
  • AURORA-2 Clinical Site
    South Miami, Florida 33143, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Tampa, Florida 33613-1244, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    The Villages, Florida 32162, United States
    Recruiting
  • AURORA-2 Clinical Site
    Winter Park, Florida 32789-4681, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Canton, Georgia 30115, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Decatur, Georgia 30030-3440, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Union City, Georgia 30291-2085, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Boise, Idaho 83704, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Schaumburg, Illinois 60173, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Evansville, Indiana 47714-7513, United States
    Recruiting
  • AURORA-2 Clinical Site
    Indianapolis, Indiana 46254, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Valparaiso, Indiana 46383, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Kansas City, Kansas 66112, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Baton Rouge, Louisiana 70809-3416, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Metairie, Louisiana 70006, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Bowie, Maryland 20715, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Rockville, Maryland 20854-2931, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Southfield, Michigan 48076-5412, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Mankato, Minnesota 56001, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Gulfport, Mississippi 39503-2637, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Jackson, Mississippi 39206, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Olive Branch, Mississippi 38654-3514, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Columbia, Missouri 65201, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    St Louis, Missouri 63141, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Las Vegas, Nevada 89113, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Jersey City, New Jersey 07306-4004, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    East Northport, New York 11731, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    East Syracuse, New York 13057, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    New Windsor, New York 12553-7754, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Charlotte, North Carolina 28262, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Durham, North Carolina 27701, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Greenville, North Carolina 27834-5051, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Morehead City, North Carolina 28557, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Raleigh, North Carolina 27610, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Cincinnati, Ohio 45246, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Cleveland, Ohio 44122-4330, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Columbus, Ohio 43212-3122, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Dayton, Ohio 45414, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Oklahoma City, Oklahoma 73118-2872, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Eugene, Oregon 97404-3233, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Philadelphia, Pennsylvania 19107, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Pittsburgh, Pennsylvania 15243-1800, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Bluffton, South Carolina 29910, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Clemson, South Carolina 29634, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Columbia, South Carolina 29204, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Gaffney, South Carolina 29340-4737, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Memphis, Tennessee 38119-4823, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Austin, Texas 78744-1645, United States
    Recruiting
  • AURORA-2 Clinical Site
    Brownsville, Texas 78520, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    DeSoto, Texas 75115-2043, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Frisco, Texas 75033-4133, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Houston, Texas 77024, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Mesquite, Texas 75149, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    San Antonio, Texas 78229-3272, United States
    Recruiting
  • AURORA-2 Clinical Site
    San Antonio, Texas 78229-3539, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Sugar Land, Texas 77478, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Tomball, Texas 77375, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Waxahachie, Texas 75165-1430, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Weslaco, Texas 78596-7288, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Wichita Falls, Texas 76301, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Salt Lake City, Utah 84124-3543, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Hampton, Virginia 23666, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Seattle, Washington 98122, United States
    Not yet recruiting
  • AURORA-2 Clinical Site
    Pardubice, 530 02, Czechia
    Not yet recruiting
  • AURORA-2 Clinical Site
    Prague, 120 00, Czechia
    Not yet recruiting
  • AURORA-2 Clinical Site
    Prague, 150 00, Czechia
    Not yet recruiting
  • AURORA-2 Clinical Site
    Uherské Hradiště, 686 01, Czechia
    Not yet recruiting
  • AURORA-2 Clinical Site
    Berlin, 10629, Germany
    Not yet recruiting
  • AURORA-2 Clinical Site
    Berlin, 10787, Germany
    Not yet recruiting
  • AURORA-2 Clinical Site
    Essen, 45355, Germany
    Not yet recruiting
  • AURORA-2 Clinical Site
    Hanover, 30159, Germany
    Not yet recruiting
  • AURORA-2 Clinical Site
    Athens, 106 76, Greece
    Not yet recruiting
  • AURORA-2 Clinical Site
    Athens, 115 27, Greece
    Not yet recruiting
  • AURORA-2 Clinical Site
    Athens, 115 28, Greece
    Not yet recruiting
  • AURORA-2 Clinical Site
    Larissa, 411 10, Greece
    Not yet recruiting
  • AURORA-2 Clinical Site
    Marousi, 151 23, Greece
    Not yet recruiting
  • AURORA-2 Clinical Site
    Palaió Fáliro, 175 62, Greece
    Not yet recruiting
  • AURORA-2 Clinical Site
    Pylaia, 570 01, Greece
    Not yet recruiting
  • AURORA-2 Clinical Site
    Thessaloniki, 546 36, Greece
    Not yet recruiting

Showing the first 100 of 135 sites across 6 countries. Choose a country and city above to see the rest.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.

Of 198 industry-sponsored phase 3 interventional studies under Obesity, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 27. This study's planned 23 months is close to that.

Counting every sponsor, half of 261 studies reached it within 24 months; a quarter within 18 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2026
First posted
Aug 3, 2026
StartActual
Aug 28, 2026
Primary completionEst.
Jul 2028
CompletionEst.
Jul 2028
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07743450
Responsible party
Sponsor
First posted
Aug 3, 2026
Start date
Aug 28, 2026
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Sep 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: ASC30

Start the discussion