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Bimagrumab + Semaglutide for Obesity
Study Summary
This trial tests a new drug combo to see if it helps overweight/obese people lose weight safely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am allergic to some specific drug types or cannot take semaglutide.I do not have chronic infections like HBV, HCV, or HIV.I haven't taken any obesity medication in the last 30 days.I have diabetes and am on medication or my HbA1c is 6.5% or higher.I am between 18 and 80 years old. If I can have children, I follow strict birth control measures.I have not donated or lost a significant amount of blood recently.My weight has been stable and is under 150 kg.I can follow the study's instructions and stick to its diet and activity plans.You have tried to lose weight before, but it hasn't been successful.
- Group 1: Bimagrumab 10 mg/kg + semaglutide 2.4 mg
- Group 2: Bimagrumab 30 mg/kg + semaglutide 2.4 mg
- Group 3: Bimagrumab 30 mg/kg + semaglutide 1.0 mg
- Group 4: Bimagrumab 10 mg/kg + semaglutide 1.0 mg
- Group 5: Placebo to bimagrumab 30 mg/kg + no semaglutide
- Group 6: Placebo + semaglutide 1.0 mg
- Group 7: Placebo + semaglutide 2.4 mg
- Group 8: Bimagrumab 10 mg/kg to bimagrumab 30 mg/kg + no semaglutide
- Group 9: Bimagrumab 30 mg/kg + no semaglutide
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are recruiting efforts still ongoing for this clinical trial?
"Evidenced by clinicaltrials.gov, this medical study is actively seeking out research participants. The trial was first announced on November 16th 2022 and the most recent changes were implemented February 1st 2023."
Who meets the criteria to enroll in this clinical experiment?
"Eligible participants must meet two criteria: be between 18-80 years old and demonstrate obesity. The trial's recruitment process is ongoing, with an estimated 450 persons sought out for participation."
Can geriatric patients participate in this research endeavor?
"As per the stated eligibility, those who wish to apply must be aged between 18 and 80. For patients younger than 18, there are 218 studies available, whereas 671 exist for participants over 65 years of age."
Does the Food and Drug Administration endorse 10 mg/kg bimagrumab?
"10 mg/kg bimagrumab is considered safe, receiving a rating of 2. This can be attributed to the Phase 2 status of this trial, indicating that while data exists confirming safety, there are no studies yet proving efficacy."
How many sites currently have this experiment underway?
"Currently, the trial is being conducted across 12 sites. These include Cullman, Hialeah and Jacksonville amongst other locations. Selecting a site close to you may be beneficial as it will reduce your travelling burden if participating in this study."
What is the maximum capacity of individuals taking part in this experiment?
"Affirmative. According to the details posted on clinicaltrials.gov, this medical investigation is actively recruiting patients - having been first shared on November 16th 2022 and most recently updated February 1st 2023. The research requires 450 individuals from 12 different sites in order to proceed."
What tangible results is this clinical trial expected to yield?
"This 48-week research project aims to observe the variation in waist circumference (WC) from baseline. Secondary outcomes include absolute change of WC (measured with a non-stretchable tape), changes to lean mass via dual energy X-ray absorptiometry, and percent alteration in fat mass by bioelectrical impedance analysis."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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Why did patients apply to this trial?
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