BridgeMD
New treatment option for Overweight Subject
Official title A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
ClinicalTrials.gov ID: NCT07331389
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for overweight subject.
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
- The purpose of this study is to characterize the drug-drug intereaction of HDM1002 and metformin, empagliflozin, midazolam, valsartan, and warfarin in overweight/obese adult subjects. The safety and tolerability of HDM1002 with metformin, empagliflozin, midazolam, valsartan, and warfarin when given separately or together will also be evaluated
- Phase 1: an early, usually small safety study
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 45. Healthy volunteers may be eligible.
You may be able to join if
- According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results...
- Age range of 18-45 years old (including range), no limit to gender.
- Subject weighed ≥50.0 kg, and a body mass index (BMI) within the range of 24.0 - 35.0 kg/m2 (including cut-off values).
You likely can't join if
- Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or...
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis attack within 3 months prior to screening.
- Severe hypoglycemic events or recurrent hypoglycemic events occurred within 3 months prior to screening
- Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal...
- Any pre-existing conditions that increase the risk of bleeding, such as acute gastritis or active ulcers with bleeding, hemorrhagic cerebral...
See the full eligibility criteria
- According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to...
- Age range of 18-45 years old (including range), no limit to gender.
- Subject weighed ≥50.0 kg, and a body mass index (BMI) within the range of 24.0 - 35.0 kg/m2 (including cut-off values).
- Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
- History of acute cholecystitis attack within 3 months prior to screening.
- Severe hypoglycemic events or recurrent hypoglycemic events occurred within 3 months prior to screening
- Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel...
- Any pre-existing conditions that increase the risk of bleeding, such as acute gastritis or active ulcers with bleeding, hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular...
- History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
- During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
- Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
- History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
- Presence of clinically significant ECG results judged by the investigator at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, 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.