ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly
ConditionAcromegaly
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAlexion Pharmaceuticals, Inc.
About this trial
The primary objective of this study is to evaluate the efficacy of 15-week treatment with ALXN2420 versus placebo for decreasing insulin-like growth factor IGF-1 levels, when administered in combination with somatostatin analog (SSA) therapy to adult participants with acromegaly.
Eligibility criteria
Qualifiers
Documented diagnosis of acromegaly, that is, historically documented evidence of a GH-secreting pituitary adenoma based on MRI or pathology report
Received for ≥ 6 months prior to screening
Receiving a once-monthly regimen (approximately every 4 weeks). Note: participants on stable regimens of other durations (for example, every 3 or 6 weeks) are not eligible
Must be a partial responder to SSAs defined as > 20% relative IGF 1 reduction during the course of SSA therapy
Disqualifiers
Had surgery for pituitary adenoma within the last 6 months before Day 1 or planning to receive surgery for pituitary adenoma during the study
Pituitary adenoma that, per Investigator's judgment, is worsening as assessed by pituitary/sellar MRI or computed tomography scan obtained ≤ 6 months prior to screening
Pituitary adenoma causing compression of the chiasm
Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment with dopamine agonists
Trial design
Treatments tested in this trial
- ALXN2420
- Placebo
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov