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New treatment option for Overweight and Obese Volunteers
Official title 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
ClinicalTrials.gov ID: NCT06778850
What this study is testing
What is MDR-001?
MDR-001 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for overweight and obese volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent; no gender restriction.
- Participants with 27 ≤ body mass index (BMI) ≤ 45 kg/m2.
- For male participants, a waist circumference ≥ 90 cm is required, while female participants ≥ 85 cm.
You likely can't join if
- 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...
- Participants with a history of pancreatitis or symptomatic gallbladder disease.
- Serum calcitonin \> ULN at screening.
- Participants with systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg at screening.
- Participants with ALT \>2 × ULN and /or AST \> 2 × ULN at screening.
See the full eligibility criteria
- Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent; no gender restriction.
- Participants with 27 ≤ body mass index (BMI) ≤ 45 kg/m2.
- For male participants, a waist circumference ≥ 90 cm is required, while female participants ≥ 85 cm.
- 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.
- Serum calcitonin \> ULN at screening.
- Participants with systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg at screening.
- Participants with ALT \>2 × ULN and /or AST \> 2 × ULN at screening.
- Participants whose fasting triglycerides \> 5.7 mmol/L, total cholesterol \> 7.75 mmol/L, low-density lipoprotein cholesterol \> 4.9 mmol/L at screening.
- Participants with abnormal uric acid levels accompanied by clinical symptoms (those without clinical symptoms can be included).
- Participants with fasting blood glucose levels \> 7 mmol/L.
- Participants with creatinine clearance \< 60 mL/min at screening [calculation formula: CLcr: (140 - age) × weight (kg) / [72 × 0.0113 × Scr (μmol/L)], × 0.85 for females].
- Participants have experienced significant changes in diet or exercise habits or within ≥5% changes in body weight within 3 months prior to screening.
- Participants with clinically significant ECG abnormality deemed unsuitable participation for study by the investigator; or with ECG QTcF values \> 450 ms for male participants or \> 470 ms for female participants.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.