Taking people in GermanyPhase 3
Daily Oral ASC30 for Adults with Obesity or Overweight and Type 2 Diabetes
Tests daily oral ASC30 against placebo for weight in adults with type 2 diabetes.
Key facts
- Who runs it
- Ascletis Pharma (China) Co. Ltd.
- Where
- Berlin, Essen, and Hanover, GermanySee the 4 sitesAlso in 3 other countries, 39 sites
- Trial code
- Registry title
- Efficacy and Safety of Once-Daily Oral ASC30 Compared with Placebo in Participants with Obesity or Overweight with Type 2 Diabetes Mellitus
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 549 people, planned
- Started
- 7 Oct 2026
- Expected to end
- 15 Oct 2028
- Type of study
- Interventional
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity or overweight and type 2 diabetes. It compares once-daily oral ASC30 with placebo for body weight at 72 weeks.
- Age
- 18 years or older (or the legal age of consent where the study takes place).
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes with a BMI of 27 kg/m2 or more.
- Earlier treatment
- At least 1 self-reported unsuccessful try to lose weight by diet. Stable type 2 diabetes treatment for at least 90 days: diet and exercise alone, or up to 3 oral diabetes medicines. Medicines of the DPP-4 inhibitor and GLP-1 types are not allowed.
Main reasons for not taking part
- Past or planned weight-loss surgery (some body-contouring procedures more than 1 year ago are allowed)
- Type 1 diabetes, past ketoacidosis or other types of diabetes besides type 2
- Current or planned treatment for diabetic eye disease
- Body weight change of more than 5 kg (11 lb) within 3 months before screening
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM
Where in Germany
Also in 3 other countries, 39 sites
- FutureMeds GmbHBerlin, GermanyTaking people
- Velocity Clinical Research Germany GmbHBerlin, GermanyTaking people
- Dr. med. Bernd Becker Praxis am MarktEssen, GermanyTaking people
- Klinische Forschung Hannover-Mitte GmbHHanover, GermanyTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Daily Oral ASC30 for Adults with Obesity or Overweight and Type 2 DiabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 13 October 2026