The PASIPHY study is to test three doses of pasireotide to find one dose that may benefit people who had bariatric surgery more than six months ago and now experience low blood sugar levels (hypoglycemia) after having meals. This condition is known as post-bariatric hypoglycemia (PBH).
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*Other study requirements will apply.
Qualified participants will receive the study-related drugs and study-related care at no cost. Participants may be compensated for reasonable expenses such as travel and lodging, if needed.
Take the pre-screener now to see if you may qualify!
The PASIPHY study lasts up to 59 weeks. If you decide to participate, you can expect the following steps:
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Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Take the pre-screener now to see if you may qualify!
Take the Pre-ScreenerFor more information on the study visit the following link: https://clinicaltrials.gov/study/NCT05928390
The study medication is called pasireotide. It has been approved by regulatory authorities for treating certain conditions, but not for post-bariatric hypoglycemia (PBH). In this study, researchers are testing if pasireotide can safely help control insulin release in people with PBH, so the body can maintain normal blood sugar levels after having meals.
To learn if pasireotide will work as expected, study participants are randomly assigned to receive either pasireotide or a placebo that does not have any medication, for 12 weeks.
For every 4 participants in the study, 3 will receive pasireotide and 1 will receive placebo (no active ingredient). You have a 75% chance of receiving the study drug during the first 12 weeks of the trial. All participants then have the option to continue in the study for a further 36 weeks. At this stage, all eligible participants will receive pasireotide.
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PBH is a rare condition. It affects people who had a bariatric surgery and now experience low blood sugar levels (hypoglycemia) after having meals. PBH happens because the food is emptied too quickly from the stomach, resulting in an insulin increase and a fall in blood glucose levels. There is currently no approved medication for PBH.
Symptoms can include lightheadedness, sweating, flushed skin, fatigue/weakness, dizziness, confusion, palpitations, anxiety, numbness of the lips, slurred speech, blurred vision, and rarely more serious neurological manifestations.
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, and/or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and undergoing assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical trial, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you. Contact the study clinic to learn more.