Overweight and Obese VolunteersPhase 1/2NCT06778850
A Phase I/IIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese/ Overweight Participants
A Phase 1/2 study testing MDR-001 and palcebo in people with Overweight and Obese Volunteers, run by MindRank AI Ltd at 1 site in China.
Trial summary
To investigate the safety and tolerability after single and multiple ascending doses of MDR-001 Tablets administered orally in healthy participants and obese/ overweight participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obese Volunteers
- What is being tested?
- MDR-001 and palcebo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2023to 30 Sep 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese/ Overweight Participants
To investigate the safety and tolerability after single and multiple ascending doses of MDR-001 Tablets administered orally in healthy participants and obese/ overweight participants.
- Conditions
- Overweight and Obese Volunteers
- Being tested
- MDR-001, palcebo
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDR-001Drug
Oral administration of small molecule MDR-001 tablets
palceboDrug
Administered orally placebo
| Study group | Role | What they receive |
|---|---|---|
| MDR-001（SAD） | Experimental | Single doses of MDR-001 administered orally. Receives: Drug: MDR-001 |
| Placebo (SAD) | Experimental | Placebo administered orally. Receives: Drug: palcebo |
| MDR-001 (MAD) | Experimental | Multiple doses of MDR-001 administered orally. Receives: Drug: MDR-001 |
| Placebo (MAD) | Experimental | Placebo administered orally. Receives: Drug: palcebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Day 84
Secondary outcomes (5)
PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001
PK: AUC of MDR-001
Measured: Baseline through Day 84
Change from Baseline in Fasting Glucose
Change from Baseline in Fasting Glucose
Measured: Baseline through Day 84
Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001
PK: Cmax of MDR-001
Measured: Baseline through Day 84
Change from Baseline in Glycated Hemoglobin (HbA1c)
Change from Baseline in HbA1c
Measured: Baseline through Day 84
Change from Baseline in Body Weight
Change from Baseline in Body Weight
Measured: Baseline through Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start9 Jun 2023
- Primary completion15 Jul 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and Obese VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- MindRank AI Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778850
- Sponsor's protocol ID
- MDR-001-CN-01
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese/ Overweight Participants
- ClinicalTrials.gov ID
- NCT06778850
- Acronym / sponsor ID
- MDR-001-CN-01
- Conditions
- Overweight and Obese Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- MindRank AI LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety and tolerability after single and multiple ascending doses of MDR-001 Tablets administered orally in healthy participants and obese/ overweight participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MDR-001（SAD） | Experimental | Drug: MDR-001Single doses of MDR-001 administered orally. |
| Placebo (SAD) | Experimental | Drug: palceboPlacebo administered orally. |
| MDR-001 (MAD) | Experimental | Drug: MDR-001Multiple doses of MDR-001 administered orally. |
| Placebo (MAD) | Experimental | Drug: palceboPlacebo administered orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDR-001Oral administration of small molecule MDR-001 tablets | Drug | MDR-001 (MAD), MDR-001（SAD） |
| palceboAdministered orally placebo | Drug | Placebo (MAD), Placebo (SAD) |
Primary outcome
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through Day 84
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
5 secondary outcomes
PK: Area Under the Concentration Versus Time Curve (AUC) of MDR-001
Time frame: Baseline through Day 84
Change from Baseline in Fasting Glucose
Time frame: Baseline through Day 84
Pharmacokinetics (PK): Maximum Concentration (Cmax) of MDR-001
Time frame: Baseline through Day 84
Change from Baseline in Glycated Hemoglobin (HbA1c)
Time frame: Baseline through Day 84
Change from Baseline in Body Weight
Time frame: Baseline through Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MDR-001 and palcebo in people with Overweight and Obese Volunteers, run by MindRank AI Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.