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A Phase III Study of ASC30 Sodium for Weight Loss in Adults with Obesity or Overweight and Type 2 Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have Obesity or are overweight and also have Type 2 Diabetes Mellitus. Obesity means having excess body fat that can affect health, while Type 2 Diabetes Mellitus is a condition where the body has trouble controlling blood sugar levels. The medication being tested is an oral tablet called ASC30, which participants would take once each day.

The aim of the study is to find out whether taking ASC30 leads to greater weight loss than taking an inactive tablet (placebo) over a period of about 72 weeks. Participants would be randomly assigned to receive either ASC30 or the placebo and would follow the same schedule of daily dosing. Throughout the study, they would attend regular visits where simple measurements such as body weight, the size of the waist (waist circumference), the top number of blood pressure (systolic blood pressure), and basic blood tests for cholesterol and triglycerides would be taken. A placebo is a tablet that looks like the study drug but does not contain any active ingredient, and it is used to compare the effects of the real medication.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and assessments

    You attend the first study visit after joining the trial. during this visit, the study team records your medical history, measures your weight, waist size, and blood pressure, and collects blood samples to check cholesterol and other values. these measurements serve as the starting point for later comparisons.

  2. Step 2

    Randomization to treatment

    Based on a computer‑generated system, you are assigned to receive either asc30 tablets or matching placebo tablets. the assignment is double‑blind, meaning neither you nor the study staff know which one you receive.

  3. Step 3

    Start of daily medication

    You begin taking one tablet by mouth each day. the tablet is taken with water, at the same time each day, for a total period of 72 weeks. the exact amount of active substance is not disclosed, but the schedule is once‑daily.

  4. Step 4

    Regular follow‑up visits

    You return to the study site at scheduled intervals, typically every four weeks, for the duration of the trial. at each visit, the staff measures your weight, waist circumference, and blood pressure, and may draw a small blood sample to monitor cholesterol and other safety parameters.

    Any symptoms or side effects you experience are recorded and reviewed to ensure safety.

  5. Step 5

    Continuation of medication

    You continue to take the assigned tablet each day for the full 72‑week period, unless advised otherwise by the study doctor because of safety concerns.

  6. Step 6

    Final assessment at week 72

    At the end of week 72, you attend a final study visit. the same measurements taken at baseline—weight, waist circumference, blood pressure, and blood tests—are repeated.

    The primary goal of the trial is to compare the percent change in your weight from the start to week 72 between the asc30 group and the placebo group.

  7. Step 7

    Study completion

    After the final assessments, the study medication is stopped. you may receive information about the overall study results, but no further study‑specific procedures are required.

Who can join the trial?

5 criteria

  • Age: You must be at least 18 years old, or old enough to give legal consent where the study is being done.
  • Body‑mass index (BMI) of 27 kg/m² or higher: BMI is a number that compares your weight to your height to tell if you are overweight.
  • You must have tried at least one diet or eating plan that did not help you lose weight.
  • Stable treatment for Type 2 Diabetes Mellitus (T2DM) for at least 90 days before screening: This means you have been on the same diabetes care for three months, which can be:
    • diet and exercise only, or
    • up to three oral blood‑sugar‑lowering pills (called antihyperglycemic medications), but not the newer injectable or advanced medicines such as DPP‑4 inhibitors, GLP‑1 receptor agonists, GLP‑1/GIP dual agonists, GLP‑1/GIP/GCGR triple agonists, amylin receptor agonists, or combinations of GLP‑1 and amylin agonists.

Who cannot join the trial?

4 criteria

  • Having had or planning a surgical treatment to reduce obesity, unless it was a cosmetic procedure such as liposuction (removing fat through small tubes), abdominoplasty (a “tummy tuck”), or cryolipolysis (freezing fat), and those procedures were performed more than one year before screening.
  • Having Type 1 Diabetes Mellitus (a form of diabetes where the body cannot produce insulin), a history of diabetic ketoacidosis (a dangerous buildup of acids in the blood) or a hyperosmolar state/coma (extremely high blood sugar that can cause loss of consciousness), or any type of diabetes other than Type 2.
  • Currently receiving or planning eye treatment for diabetic retinopathy (damage to the back of the eye caused by diabetes) or macular edema (swelling in the central part of the retina). This includes treatments such as laser photocoagulation (using a laser to seal leaking blood vessels) or intravitreal injections (injections into the eye) of anti‑vascular endothelial growth factor medicines that stop abnormal blood vessel growth.
  • Reporting a change in body weight of more than 5 kg (about 11 pounds) within the three months before the screening visit.
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Investigated drugs

ASC30 is an experimental oral tablet being tested in this study. It contains a compound called ASC30 sodium and is taken by mouth once each day. The purpose of the medication in the trial is to see if it can help adults who are overweight or have obesity and also have type 2 diabetes lose weight over a period of about 72 weeks. Researchers are comparing the effects of ASC30 to a placebo to determine whether it is safe and effective for weight reduction in this group of participants.

What is already known about the treatment

ASC30 - ASC30 is taken as a tablet taken by mouth once a day. It is an investigational drug that is still being studied in clinical trials and has not yet been approved for general medical use. The medication is being tested to help adults who are overweight or have obesity together with type 2 diabetes. It works by influencing the body’s metabolism and appetite‑control pathways, and it is classified as an oral anti‑obesity agent under investigation.

Investigated diseases

Obesity with type 2 diabetes mellitus - This condition combines excess body weight with a chronic disorder that raises blood sugar levels. The excess fat, especially around the abdomen, makes the body less able to use insulin, a hormone that controls glucose. Over time, the pancreas works harder to produce more insulin, and blood sugar levels begin to rise. The high sugar and extra weight can cause the disease to become more widespread throughout the body. Without changes, the condition usually worsens gradually, leading to larger increases in weight and higher blood glucose.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526336-39-00Protocol codeASC30-302Estimated enrolment1 560 patients

sourced from the EU Clinical Trials Register and site verification

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