This study includes a Screening Period and a Treatment Period. The Screening Period is up to 12 weeks and consists of 2 to 3 visits. After the Screening Period, subjects will be enrolled in a 36-week Treatment Period with approximately 11 planned visits.
Subjects will be divided by chance in a 1:1 ratio to receive either paltusotine or placebo (placebo tablets will look identical to the paltusotine tablets but not contain paltusotine or any other study medication).
At the end of the Treatment Period, subjects who in the opinion of the investigator may benefit from treatment with paltusotine, may be enrolled in a long-term, open label extension (OLE) for up to 96 weeks. During the OLE, all subjects will receive paltusotine.