ACCOMPLISH-1 and ACCOMPLISH-2 are testing different doses of an investigational study drug over 76 weeks to see if it could help reduce body weight. They will also check for any side effects participants may experience. The investigational study drug will be compared with a placebo. A placebo looks like the investigational study drug but contains no medically active ingredients.
ACCOMPLISH-1 could last up to 81 weeks, including a 4-week screening period to see if you can take part, a 76-week study treatment period, during which you will receive either the investigational study drug or placebo, and an end of study visit 1 week after your last dose.
ACCOMPLISH-2 could last up to 85 weeks, including an optional prescreening visit (up to 8 weeks before study treatment starts) to see if the study may be a good fit for you, a 4-week screening period to see if you can take part, a 76-week study treatment period, during which you will receive either the investigational study drug or placebo, and an end of study visit 1 week after your last dose.
In ACCOMPLISH-1, for approximately every 7 enrolled participants, 5 participants will receive the investigational study drug and 2 participants will receive placebo.
In ACCOMPLISH-2, for every 10 enrolled participants, 6 participants will receive the investigational study drug and 4 participants will receive placebo.
In ACCOMPLISH-1 and ACCOMPLISH-2, study treatment is a tablet taken orally (by mouth) once daily. The dosage (the amount you take) will be increased every 4 weeks until you reach your target dose.
During ACCOMPLISH-1, you will have tests at the study center or by phone every 4 weeks. These tests will monitor your health and see how you are responding to study treatment. Over 81 weeks, you will visit the study center up to 17 times and receive 5 phone calls.
During ACCOMPLISH-2, you will have tests at the study center or by phone every 4 weeks. These tests will monitor your health and see how you are responding to study treatment. Over 81–85 weeks, you will visit the study center up to 17 or 18 times (depending on whether you had a prescreening visit) and receive 5 phone calls.