A pill for obesity? early human trial puts MDR-001 to the test

NCT ID NCT06778850

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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