2026-526336-39-00RecruitingPhase 3
Efficacy and Safety of Once-Daily Oral ASC30 Compared with Placebo in Participants with Obesity or Overweight with Type 2 Diabetes Mellitus
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Oct 2026
Brief summary (registry, in English)
To demonstrate that dose 1, dose 2, and/or dose 3 once-daily oral ASC30 is superior to placebo for body weight at 72 weeks.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 549 (estimated)
- First submitted
- 10 Jun 2026
- Start date
- 7 Oct 2026
- Lead sponsor
- Ascletis Pharma (China) Co. Ltd.
- Diseases
- Obesity, Type 2 diabetes
- EU CT number
- 2026-526336-39-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 549
- 43 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have a prior or planned surgical treatment for obesity (excluding Liposuction, Abdominoplasty, or Cryolipolysis, if performed >1 year prior to screening).
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of antivascular endothelial growth factor inhibitors). Note: all participants will have a baseline fundus photography assessment. In the presence of any degree of diabetic retinopathy and/or macular edema, further ophthalmologic assessment will be performed to confirm eligibility.
- Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening.
Other illness
- Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
Who the study is looking for
- 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.
- Are on stable treatment for T2DM for at least 90 days prior to screening, consisting of: - either diet/exercise alone, or - up to 3 oral antihyperglycemic medications (AHMs) (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), GLP-1R/GIPR dual agonists, GLP-1R/GIPR/GCGR triple agonists, amylin receptor agonists or GLP-1 receptor and amylin receptor dual agonists)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (43)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pratia Czech s.r.o. | Pardubice | Czechia | Recruiting |
| Synexus Czech s.r.o. | Praha 2 | Czechia | Recruiting |
| Praglandia s.r.o. | Praha 5 | Czechia | Recruiting |
| Clinical Trials Service s.r.o. | Uherské Hradiště | Czechia | Recruiting |
| Velocity Clinical Research Germany GmbH | Berlin | Germany | Recruiting |
| FutureMeds GmbH | Berlin | Germany | Recruiting |
| Dr. med. Bernd Becker Praxis am Markt | Essen | Germany | Recruiting |
| Klinische Forschung Hannover-Mitte GmbH | Hanover | Germany | Recruiting |
| Areteio Hospital | Athens | Greece | Recruiting |
| Evangelismos S A | Athens | Greece | Recruiting |
| Thoracic General Hospital of Athens "I Sotiria" | Athens | Greece | Recruiting |
| General University Hospital of Larissa | Larissa | Greece | Recruiting |
| Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. | Maroussi | Greece | Recruiting |
| Athens Medical Center S.A. | Paleo Faliro | Greece | Recruiting |
| University General Hospital of Thessaloniki - AHEPA | Thessaloniki | Greece | Recruiting |
| Athens Medical Center S.A. | Thessaloniki | Greece | Recruiting |
| Ippokratio General Hospital of Thessaloniki | Thessaloniki | Greece | Recruiting |
| ETG Biała Podlaska | Biała Podlaska | Poland | Recruiting |
| Centrum Medyczne "Hipokrates" s.c. Elżbieta i Grzegorz Grześk | Bydgoszcz | Poland | Recruiting |
| Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o. | Cracow | Poland | Recruiting |
| Synexus Polska Sp. z o.o. | Czestochowa | Poland | Recruiting |
| Synexus Polska Sp z o.o. | Gdansk | Poland | Recruiting |
| Synexus Polska Sp. z o.o. | Gdynia | Poland | Recruiting |
| FutureMeds Gdynia | Gdynia | Poland | Recruiting |
| Synexus Polska Sp. z o.o. | Katowice | Poland | Recruiting |
| FutureMeds Krakow | Krakow | Poland | Recruiting |
| Synexus Polska Sp. z o.o. | Lodz | Poland | Recruiting |
| FutureMeds Łódź | Łódź | Poland | Recruiting |
| Velocity Nova Sp. z o.o. | Lublin | Poland | Recruiting |
| Clinical Best Solutions Sp. z o.o., Sp. K. | Lublin | Poland | Recruiting |
| Synexus Polska Sp z o o | Poznan | Poland | Recruiting |
| Twoja Przychodnia PCM | Poznan | Poland | Recruiting |
| Velocity Nova Sp. z o.o. | Pulawy | Poland | Recruiting |
| Lukmed 2 Sp. z o.o. | Siedlce | Poland | Recruiting |
| Velocity Nova Sp. z o.o. | Staszow | Poland | Recruiting |
| Mics Centrum Medyczne Torun | Torun | Poland | Recruiting |
| Synexus Polska Sp. z o.o. | Warsaw | Poland | Recruiting |
| Centrum medyczne Justmed Sp. z o.o. | Warsaw | Poland | Recruiting |
| Clinical Best Solutions Sp. Z O.O. Sp.K. | Warsaw | Poland | Recruiting |
| Futuremeds Targówek | Warszawa | Poland | Recruiting |
| FutureMeds Warszawa Centrum | Warszawa | Poland | Recruiting |
| Synexus Polska Sp. z o.o. | Wroclaw | Poland | Recruiting |
| FutureMeds Wrocław | Wrocław | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.