A pill for obesity? early human trial puts MDR-001 to the test
NCT ID NCT06778850
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing an experimental oral drug called MDR-001 in healthy adults and in people who are overweight or obese. The trial gives single and increasing repeated doses to see how the body processes the drug and whether it causes side effects. They also measure changes in blood sugar and other metabolic markers. The goal is to learn whether this pill is safe enough to study further as a possible treatment for weight and blood sugar problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental oral small-molecule drug called MDR-001
- What this could lead to
- If it works, this could point toward a new oral pill for weight and blood sugar control. That would give people an option beyond injections.
- What could go wrong
- This is an early-stage trial with about 128 people, so most experimental drugs fail before reaching the market. Side effects may appear, and the drug may not lower weight or blood sugar enough to matter.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
128 people
The number who actually took part.
- Started
-
Jun 2023
- Finished
-
Sep 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main inclusion criteria: * Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent, no gender restriction. * Participants with body weight ≥ 50 kg for males, and ≥ 45 kg for females; 18 ≤ body mass index (BMI) \< 25 kg/m2 for healthy participants, and 25 ≤ BMI ≤ 35 kg/m2 for obese/overweight participants. * For healthy participants, physical examination and vital signs must be normal, or abnormal but clinically insignificant. For obese/overweight participants, physical examination and vital signs must be normal, or abnormal but clinically insignificant, and the vital signs should be within following ranges: systolic blood pressure: 90-150 mmHg; diastolic blood pressure: 50-95 mmHg. Main exclusion criteria: * Participants with any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers. * Participants with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or those with hereditary diseases that easily induce to medullary thyroid carcinoma. * Participants with a history of pancreatitis or symptomatic gallbladder disease. * Participants with serum calcitonin levels above the upper limit of normal (ULN) at screening. * Participants with significant changes in diet or exercise habits within 3 months prior to screening. * Participants with clinically significant electrocardiogram abnormality; or ECG QTcF values \> 450 ms for males or \> 470 ms for females. * Participants with clinically significant abnormalities in laboratory examinations (obese/overweight participants with triglycerides ≤ 5.7 mmol/L, total cholesterol ≤ 7.75 mmol/L, low-density lipoprotein cholesterol ≤ 4.9 mmol/L, and fasting blood glucose ≤ 7 mmol/L can be included); or those with clinically significant findings indicating the following diseases within 12 months prior to screening, including but not limited to disorders of respiratory system, circulatory system, digestive system, endocrine system, rheumatological/immune system, nervous system, and blood system, and mental/psychological disorders, which are considered by the investigator as inappropriate for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The first hospital of Jilin University
Changchun, Jilin, China
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Other studies related to the condition(s) this trial covers.
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