A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)

This study is specifically looking for adults between 18 and 75 years old who have already completed one of the earlier paltusotine studies (ACROBAT Evolve or ACROBAT Edge). If you're a woman, you must not be pregnant or breastfeeding, and you should either have had a sterilisation operation, be past menopause, or be using reliable birth control methods.

You won't be able to join if you have certain other health issues, such as serious heart, kidney, or liver problems. You also can't have had radiation treatment for your pituitary gland since finishing the earlier study, or have had certain types of cancer within the last five years. There are also checks for infections like HIV or hepatitis, and you shouldn't have a history of alcohol or drug abuse in the past year. If you're taking another experimental drug, you'd also be unable to join.

Ultimately, whether you can take part will also depend on the opinion of the study doctor, who will make sure it's safe for you and that you're a good fit for the research.

If you decide to take part, you'll continue to take the study medicine, paltusotine, as directed. You'll have regular hospital or clinic visits where the study team will monitor your health, check for any side effects, and see how well the medicine is working. This will involve physical examinations, blood tests, and possibly other tests to measure your hormone levels and overall health. The specific number of visits and tests will be explained in detail by the study team. You'll be in touch with the research staff frequently, and they'll be there to support you throughout the study. The total duration of your participation will be discussed with you, but as it's a long-term extension study, it will likely involve several months or even longer.