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Efficacy and Safety of Once‑Daily Oral ASC30 in Adults with Obesity or Overweight: A Phase III Randomized Placebo‑Controlled Trial

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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 classified as Overweight and who may have health problems related to excess weight. The investigational medication is an oral tablet called ASC30, taken once each day at a dose of 60 mg. A matching placebo tablet, which looks the same but contains no active drug, is also used for comparison.

The purpose of the trial is to determine whether daily use of ASC30 leads to a greater reduction in body weight than the placebo over a period of about 72 weeks. Participants will be assigned to receive either the active tablet or the placebo and will attend regular study visits where their waist circumference (the measurement around the belly), SBP (the top number of a blood pressure reading), non‑HDL cholesterol (a type of blood fat linked to heart risk), and triglycerides (another type of blood fat) are checked, along with their weight. The study follows a simple schedule of daily medication and periodic health assessments without requiring any complex procedures.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline visit and randomization
You will attend an initial clinic visit where your weight, waist size, blood pressure, and blood samples will be measured. this information establishes the starting point for the study.
Based on the study design, you will be randomly assigned to receive either ASC30 tablets or placebo tablets. the tablets look the same, but the placebo contains no active ingredient.
Step 2
Start taking study medication
You will begin taking one 60 mg ASC30 tablet (or matching placebo tablet) by mouth each day. the dose is taken once daily, preferably at the same time each day, for a total of 72 weeks.
The tablet should be swallowed with water and can be taken with or without food.
Step 3
Regular follow‑up visits
Throughout the 72‑week period you will return to the clinic at intervals defined by the study team. at each visit your weight, waist circumference, and blood pressure will be measured again.
Blood samples will be collected to check changes in cholesterol and triglycerides. these measurements help determine how the medication affects your body over time.
The study staff will also ask about any side effects you may experience and will perform safety checks as needed.
Step 4
Final assessment and end of treatment
At week 72 you will have a final clinic visit. the same measurements taken at baseline (weight, waist size, blood pressure, cholesterol, triglycerides) will be repeated.
After the final assessment you will stop taking the study tablets. the study will then be complete for you.

Who can join the trial?

5 criteria

Be able to sign a form that shows you understand the study and agree to take part, and follow the study rules.
Be at least 18 years old (or the legal age required in your country).
Have a body‑mass index (BMI) of 30 kg/m² or higher, or a BMI of 27 kg/m² or higher if you also have at least one weight‑related health problem such as heart disease (problems with the heart and blood vessels), high blood pressure (called hypertension), high blood fats (dyslipidemia), or breathing problems while sleeping (obstructive sleep apnea).
Have tried a diet to lose weight before and not been successful.
Not be currently pregnant or breastfeeding, and be willing to use birth control methods if required by local rules.

Who cannot join the trial?

6 criteria

Having been diagnosed with diabetes mellitus (type 1, type 2, or any other form) at any time.
Having had ketoacidosis, a serious condition where the body builds up high levels of acidic substances called ketones.
Having experienced a hyperosmolar state or coma, a severe emergency caused by extremely high blood sugar.
Gaining or losing more than 5 kg (about 11 pounds) in body weight during the three months before screening.
Having a past history of acute or chronic pancreatitis, which is inflammation of the pancreas that can be sudden or long‑lasting.
Having a personal or first‑degree family member with medullary thyroid carcinoma (a type of thyroid cancer) or multiple endocrine neoplasia type 2 (a genetic condition that can cause tumors in several glands).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

FutureMeds Kraków
Verified
Cracow, Poland
Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland
Futuremeds Łódź
Responsive
Lodz, Poland
Synexus Polska Sp. z o.o.
Verified
Poznan, Poland

Trial locations

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Investigated drugs

ASC30 is an oral tablet taken once each day. It contains a substance called ASC30 sodium. In this study, participants with obesity or who are overweight and have related health problems take the tablet to see if it helps them lose weight. The researchers are comparing the amount of weight loss in people who take ASC30 with those who take a placebo, over a period of 72 weeks, to determine if the medication is effective and safe for long‑term use.

What is already known about the treatment

ASC30 - ASC30 is taken as a 60 mg oral tablet taken once each day. It is currently an investigational drug being studied in Phase III trials and is not yet approved for general medical use. The tablet is being tested to help adults who are obese or overweight and have related health problems by supporting weight loss. It works by gently influencing the body’s metabolism and appetite signals, and it is classified as an anti‑obesity metabolic agent.

Investigated diseases

Obesity - Obesity is a condition where excess body fat accumulates to a level that may affect health. It develops when energy intake consistently exceeds energy expenditure over time. As weight increases, the amount of fat stored in the body grows, often starting around the abdomen and spreading to other areas. The excess fat can lead to gradual changes in metabolism and increase the strain on the cardiovascular system. Without changes in lifestyle, body weight tends to continue rising, making it harder to lose weight later.