The clinical trial begins with a prescreening call that typically lasts 10 to 15 minutes. The call is made by a research coordinator, who asks direct questions, some of which might be confidential, to determine your eligibility to join the program. If they are satisfied with your answers and believe that you could be a good candidate, the coordinator will schedule a physical meeting for in-person screening.
The in-person visit will last only one day. The screening process involves obtaining your informed consent and reviewing your medical history. The informed consent includes educating you about the clinical trial and ensuring that you understand its benefits, expectations, and possible disadvantages. The coordinator will require your consent before proceeding with reviewing your medical history. They will also take your vitals, run an ECG, conduct a blood test, and, if possible, run a pregnancy test. Lastly, they will review your current medication and lifestyle.
The third step typically involves randomization and administration of the first dose. If, from the screening steps above, you qualify for the clinical trial, a coordinator will randomly assign you to an investigational injection or a placebo. If you are chosen for an injectable, they will train you on how to inject yourself and the plan for your dosage. Ensure you understand these clearly, as the success of the program depends on how well the clinical trial proceeds.
There will be regular follow-up visits, which can occur every 2 to 4 weeks, to evaluate your progress. During these study visits, the coordinator will check your vital signs, weight, and waist circumference. They will also run some lab tests at intervals, including HbA1C. The coordinator will also check for any side effects and tolerability and write a report. You will be counseled on the lifestyle changes you need to make or adapt, which are in line with the program. At the end of each visit, the coordinator will refill your study medication for at-home administration.
If you are tolerating the program well, you will remain in it for the required period (from 56 to 72 weeks). Once the coordinator is satisfied with your results, they will end your treatment. However, a final assessment must be conducted to determine the program’s success and determine the next steps the coordinator must take.