You will enter a screening period to determine if you qualify for the study. During this time, you’ll need to complete a Carcinoid Syndrome Symptom Diary for 2 weeks, recording your daily flushing episodes and bowel movements.

If you’re currently taking somatostatin receptor ligands (SRLs), you’ll need to stop this medication and go through a washout period. During the washout, you’ll need to show an increase in flushing episodes with an average of more than 1 flushing episode per day over 14 days.

A CT or MRI scan will be performed to assess your disease status.

After qualifying, you’ll be randomly assigned to one of two groups: either the paltusotine group or the placebo group.

Neither you nor your doctor will know which group you’re in during the study.

The treatment period lasts for 12 weeks.

If you’re in the paltusotine group, you’ll take paltusotine 40 mg tablets daily.

If you’re in the placebo group, you’ll take placebo tablets that look identical to the paltusotine tablets.

You’ll need to continue completing your Carcinoid Syndrome Symptom Diary throughout the 12-week treatment period, recording your flushing episodes and bowel movements daily.

You’ll attend regular study visits where healthcare providers will monitor your health and assess how you’re responding to treatment.

These visits will include physical examinations, vital sign measurements, and possibly blood tests to evaluate your condition.

The healthcare team will review your symptom diary and ask about any side effects you may be experiencing.

At the end of the 12-week treatment period, a final assessment will be conducted.

The main focus will be comparing your average number of flushing episodes per day at the end of the study versus when you started.

A secondary focus will be comparing your average number of bowel movements per day at the end of the study versus when you started.

After completing the treatment period, you’ll enter a follow-up period for at least 2 weeks after your last dose.

During this time, you’ll need to continue using contraception if applicable (as detailed in the study requirements).

Male participants should continue to use condoms when sexually active with female partners of childbearing potential for at least 2 weeks after the last dose.