Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine

Area of Science:

• Endocrinology
• Pharmacology
• Clinical Trials

Background:

• Paltusotine is an oral, selective somatostatin receptor 2 agonist.
• It is under development for once-daily treatment of acromegaly.

Purpose of the Study:

• To assess the efficacy and safety of paltusotine.
• To evaluate its use in acromegaly patients previously controlled with injectable somatostatin receptor ligands (SRLs).

Main Methods:

• Phase 3, randomized, double-blind, placebo-controlled trial.
• Adult acromegaly patients on stable injectable SRLs were switched to oral paltusotine or placebo for 36 weeks.
• Primary endpoint: maintaining IGF-I ≤1.0× ULN.

Main Results:

• 83.3% of paltusotine patients maintained IGF-I ≤1.0× ULN versus 3.6% on placebo (P < .0001).
• Paltusotine demonstrated superiority in secondary endpoints, including IGF-I levels, symptom scores, and growth hormone (GH) control.
• Adverse events included acromegaly symptoms and gastrointestinal effects.

Conclusions:

• Oral paltusotine effectively maintains biochemical and symptom control in acromegaly.
• It serves as an effective replacement for injected SRLs and is well-tolerated.