The study is being conducted at clinical investigative sites in the US and Canada. For a full list of sites, please click here.
If you wish to be considered for participation in the study, or if you would like to receive more information, please contact the study Sponsor using the information below. The Study sponsor will be able to direct you to a participating site near your home. You would undergo an initial evaluation to find if you are eligible to participate.
If you are eligible to participate, you will make periodic visits over an approximately 5-month period to the study site nearest to your home.
Your participation in the study would be supervised by a team of medical professionals. You will provide blood samples at designated time points throughout the study.
To make it easier to participate, you may have the option for a nurse to come to your home to collect blood samples in place of you coming to the site for selected study visits although not all sites will have the ability to offer this service to you.
Travel costs to participate in the study may also be reimbursed by HighTide.
Although the study does involve a comparison with placebo (a substance that is made to look like HDT1801 but has no active ingredient), everyone who participates in all 18 weeks of the study will receive HTD1801 for a minimum of 6 weeks. Some participants will receive HTD1801 for 12 weeks, and some will receive HTD1801 for the entire 18 weeks. Whether you receive HTD1801 for 6 weeks or 12 weeks or all 18 weeks of the study will be determined by a process called randomization. Randomization is a method to assign study participants to a treatment group based on chance alone, like flipping a coin. You will not know which medication(s) you received until after the last study subject has completed the study. At that time, your study doctor will be able to tell you what medication(s) you received during your participation in the study.
During the study you will need to provide blood samples, urine samples, and stool samples for testing. A physical exam and ECGs (a tracing of your heart activity) will also be done several times over the study period to ensure your baseline health is maintained.