Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial

Abstract

ObjectiveSomapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin®. Local tolerability and treatment satisfaction were also assessed.Design26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939).MethodsMale or female patients aged 18–79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen. Both treatments were dose titrated for 8 weeks to achieve insulin-like growth factor I (IGF-I) standard deviation score (SDS) levels within the normal range, and then administered at a fixed dose. Outcome measures were adverse events (AEs), including injection site reactions; occurrence of anti-somapacitan/anti-GH antibodies and change in treatment satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9).ResultsMean IGF-I SDS remained between 0 and 2 SDS throughout the trial in both groups. AEs were mostly mild or moderate and transient in nature. The most common AEs were nasopharyngitis, headache and fatigue in both groups. More than 1500 somapacitan injections were administered and no clinically significant injection site reactions were reported. No anti-somapacitan or anti-GH antibodies were detected. The TSQM-9 score for convenience increased significantly more with somapacitan vs Norditropin (P = 0.0171).ConclusionsIn this 26-week trial in patients with AGHD, somapacitan was well tolerated and no safety issues were identified. Once-weekly somapacitan was reported to be more convenient than once-daily Norditropin.

Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials

“…This supported the dose-titration algorithm for somapacitan used in REAL (REversible ALbumin binding) 2, a phase III trial in patients with AGHD [21]. Mean IGF-I SDS values were maintained throughout the trial, remaining between 0 and 2 SDS; somapacitan was well-tolerated and no safety issues were identified.…”

Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once‐weekly somapacitan or daily growth hormone

“…Thus, reducing the frequency of injections with a long‐acting GH replacement may improve treatment adherence and persistence, and consequently treatment outcomes 7 . Johannsson et al 11 reported that once‐weekly somapacitan was rated as more convenient than daily GH by patients with AGHD. In the current trial, the evaluation of treatment satisfaction (TSQM‐9) after 52 weeks of treatment showed no statistically significant difference in convenience, effectiveness or global satisfaction scores between the somapacitan and daily GH arms.…”

Management of Hypopituitarism

“…In order to increase compliance, new compounds for GH replacement treatment are under investigation aiming to increase intra-injection intervals thus resulting in increased convenience and improved compliance, particularly in the context of the paediatric population [58]. Somapacitan, a reversible albumin-binding GH derivative, was compared in once-weekly regimen with once-daily Norditropin in a 26-week randomised, controlled, phase 3, safety and tolerability trial in AGHD patients [59]. The mean IGF-I standard deviation score (SDS) was similar for both formulations, whereas mild or moderate and transient AEs were seen for both drugs but somapacitan was associated with better treatment satisfaction.…”