ObesityPhase 3AURORA-2NCT07743450

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 study testing ASC30 tablets A1 in people with Obesity and Overweight, run by Ascletis Pharma (China) Co., Limited at 135 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity, Overweight, Chronic Weight Management
What is being tested?: ASC30 tablets A1
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,560 participants
Where: 135 sitesin 6 countries
Study dates: 28 Aug 2026to Jul 2028
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

135 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Country

City, postcode or hospital

Sites recruiting now only

135 sites in 6 countries

United States84 sites, 84 recruiting

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

Other trials in United States

Poland26 sites, 26 recruiting

AURORA-2 Clinical Site
Biała Podlaska, 21-500
Not yet recruiting
AURORA-2 Clinical Site
Bydgoszcz, 85-092
Not yet recruiting
AURORA-2 Clinical Site
Częstochowa, 42-202
Not yet recruiting
AURORA-2 Clinical Site
Gdansk, 80-382
Not yet recruiting
AURORA-2 Clinical Site
Gdynia, 81-384
Not yet recruiting
AURORA-2 Clinical Site
Gdynia, 81-537
Not yet recruiting
AURORA-2 Clinical Site
Katowice, 40-040
Not yet recruiting
AURORA-2 Clinical Site
Krakow, 31-261
Not yet recruiting
AURORA-2 Clinical Site
Krakow, 31-501
Not yet recruiting
AURORA-2 Clinical Site
Lodz, 90-127
Not yet recruiting
AURORA-2 Clinical Site
Lodz, 91-363
Not yet recruiting
AURORA-2 Clinical Site
Lublin, 20-011
Not yet recruiting
AURORA-2 Clinical Site
Lublin, 20-362
Not yet recruiting
AURORA-2 Clinical Site
Poznan, 60-324
Not yet recruiting
AURORA-2 Clinical Site
Poznan, 60-702
Not yet recruiting
AURORA-2 Clinical Site
Puławy, 24-100
Not yet recruiting
AURORA-2 Clinical Site
Siedlce, 08-110
Not yet recruiting
AURORA-2 Clinical Site
Staszów, 28-200
Not yet recruiting
AURORA-2 Clinical Site
Torun, 87-100
Not yet recruiting
AURORA-2 Clinical Site
Warsaw, 00-215
Not yet recruiting
AURORA-2 Clinical Site
Warsaw, 00-710
Not yet recruiting
AURORA-2 Clinical Site
Warsaw, 01-696
Not yet recruiting
AURORA-2 Clinical Site
Warsaw, 02-672
Not yet recruiting
AURORA-2 Clinical Site
Warsaw, 03-291
Not yet recruiting
AURORA-2 Clinical Site
Wroclaw, 50-381
Not yet recruiting
AURORA-2 Clinical Site
Wroclaw, 53-673
Not yet recruiting

Other trials in Poland

Greece9 sites, 9 recruiting

AURORA-2 Clinical Site
Athens, 106 76
Not yet recruiting
AURORA-2 Clinical Site
Athens, 115 27
Not yet recruiting
AURORA-2 Clinical Site
Athens, 115 28
Not yet recruiting
AURORA-2 Clinical Site
Larissa, 411 10
Not yet recruiting
AURORA-2 Clinical Site
Marousi, 151 23
Not yet recruiting
AURORA-2 Clinical Site
Palaió Fáliro, 175 62
Not yet recruiting
AURORA-2 Clinical Site
Pylaia, 570 01
Not yet recruiting
AURORA-2 Clinical Site
Thessaloniki, 546 36
Not yet recruiting
AURORA-2 Clinical Site
Thessaloniki, 546 42
Not yet recruiting

Other trials in Greece

United Kingdom8 sites, 8 recruiting

AURORA-2 Clinical Site
Cardiff, CF15 9SS
Not yet recruiting
AURORA-2 Clinical Site
Edgbaston, B16 8QQ
Not yet recruiting
AURORA-2 Clinical Site
Glasgow, ML43NJ
Not yet recruiting
AURORA-2 Clinical Site
London, E1 1AG
Not yet recruiting
AURORA-2 Clinical Site
Manchester, M11 1AA
Not yet recruiting
AURORA-2 Clinical Site
Manchester, M156SE
Not yet recruiting
AURORA-2 Clinical Site
Stoke-on-Trent, ST1 5SJ
Not yet recruiting
AURORA-2 Clinical Site
Warrington, WA1 3TZ
Not yet recruiting

Other trials in United Kingdom

Czechia4 sites, 4 recruiting

AURORA-2 Clinical Site
Pardubice, 530 02
Not yet recruiting
AURORA-2 Clinical Site
Prague, 120 00
Not yet recruiting
AURORA-2 Clinical Site
Prague, 150 00
Not yet recruiting
AURORA-2 Clinical Site
Uherské Hradiště, 686 01
Not yet recruiting

Other trials in Czechia

Germany4 sites, 4 recruiting

AURORA-2 Clinical Site
Berlin, 10629
Not yet recruiting
AURORA-2 Clinical Site
Berlin, 10787
Not yet recruiting
AURORA-2 Clinical Site
Essen, 45355
Not yet recruiting
AURORA-2 Clinical Site
Hanover, 30159
Not yet recruiting

Other trials in Germany

About this study

Official title: 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)

Conditions: Obesity, Overweight, Chronic Weight Management, Type 2 Diabetes Mellitus
Being tested: ASC30 tablets A1, Placebo
Keywords: Obesity, Overweight, Type 2 Diabetes
Medical subject headings: Obesity, Overweight, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASC30 tablets A1Drug
ASC30 tablets A1 administered orally once daily.
PlaceboDrug
Matching placebo tablets administered orally once daily.

Study groups in NCT07743450
Study group	Role	What they receive
ASC30 Cohort 1	Experimental	Participants will receive oral ASC30 tablets A1. Receives: Drug: ASC30 tablets A1
ASC30 Cohort 2	Experimental	Participants will receive oral ASC30 tablets A1. Receives: Drug: ASC30 tablets A1
ASC30 Cohort 3	Experimental	Participants will receive oral ASC30 tabletsA1. Receives: Drug: ASC30 tablets A1
Placebo Cohort 4	Placebo comparator	Participants will receive matching placebo tablets orally once daily. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent change from baseline in body weight
Measured: Baseline to Week 72

Secondary outcomes (10)

Change from baseline in HbA1c (%)
Measured: Baseline to Week 72
Change from baseline in fasting serum glucose (mg/dL)
Measured: Baseline to Week 72
Change from baseline in systolic blood pressure (SBP) (mmHg)
Measured: Baseline to Week 72
Percent change from baseline in fasting non-HDL cholesterol
Measured: Baseline to Week 72
Percent change from baseline in fasting triglycerides
Measured: Baseline to Week 72
Change from baseline in BMI (kg/m²)
Measured: Baseline to Week 72
Change from baseline in fasting insulin (pmol/L)
Measured: Baseline to Week 72
Change from baseline in waist circumference (cm)
Measured: Baseline to Week 72
Change from baseline in diastolic blood pressure (DBP) (mmHg)
Measured: Baseline to Week 72
Percent change from baseline in fasting total cholesterol
Measured: Baseline to Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 2026Jul 2028

First posted3 Aug 2026
Study start28 Aug 2026
Primary completionJul 2028 (estimated)
Study completionJul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,560 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07743450
Sponsor's protocol ID: ASC30-302
Acronym: AURORA-2
Status last verified: Sep 2026
First submitted: 29 Jul 2026
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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