Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,560 (estimated)
Sponsor
Ascletis Pharma (China) Co., Limited · Industry
Who this trial is looking for
This trial is looking for adults with obesity or overweight who have type 2 diabetes. Participants will take a daily oral medication to see how well it works and how safe it is over time.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesPancreatitis
You may be able to join if
I am at least 18 years old.
I have a body mass index (BMI) of 27 or higher.
I have tried to lose weight through diet but have not succeeded.
I have been diagnosed with type 2 diabetes and have certain Blood Sugar levels.
You may not be able to join if
I have type 1 diabetes.
I have gained or lost more than 11 pounds in the last 3 months.
I have severe kidney problems.
I have had pancreatitis.
I am allergic to GLP-1 receptor agonists.
I or a close family member have a history of certain thyroid cancers.
I am in another clinical study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 weigh…
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.
Contacts
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