The oPTimize study is for adults who have hypoparathyroidism (HypoPT). The study is investigating a weekly injection, called canvuparatide, to see if it may be able to help increase blood calcium levels and ease symptoms in people living with HypoPT.
Study participants may be able to join the study if they meet the following requirements:
Adults 18 years or older
Confirmed diagnosis of post-surgical chronic Hypoparathyroidism (HypoPT), genetic HypoPT, autoimmune HypoPT, or idiopathic HypoPt for at least 12 months
Other study requirements will apply
Participation in the oPTimize study lasts a little more than 2 years. Study participants can expect the following:
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.
Canvuparatide is an investigational PTH (parathyroid hormone) replacement therapy that is administered once weekly. PTH replacement therapy is designed to reduce the need for high doses of calcium and vitamin D in people with HypoPT. The oPTimize study will be investigating Canvuparatide to see if it can help raise calcium levels in the blood and potentially reduce the symptoms of HypoPT.
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Participants will be assigned by chance to receive either Canvuparatide or Placebo during the first 26 weeks of the study. Participants have a 75% chance of receiving Canvuparatide and a 25% chance of being assigned to the placebo group. After 26 weeks, participants will be moved into the 78-week open-label part of the study where everyone will receive the study drug, Canvuparatide.
“Investigational” means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), and it can only be used in clinical research studies like oPTimize.
Hypoparathyroidism (HypoPT) is a rare disorder that affects the parathyroid glands in the neck. In the United States, it is estimated to affect about 37 out of every 100,000 people each year. Parathyroid glands help regulate calcium levels in the blood by releasing parathyroid hormone (PTH). When someone has HypoPT, the parathyroid glands do not make enough PTH. Without enough of this hormone, calcium levels in the blood can drop too low, which leads to complications.
Other symptoms may apply.
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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, 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 having 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 research study, 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.