CLINICAL TRIAL OF AN ORAL ALTERNATIVE

If approved as the first oral somatostatin analog treatment for acomegaly, octreotide capsules may offer an alternative to intramuscular or deep subcutaneous injections.

MPOWERED is a phase 3, randomized, open-label, active controlled, multicenter study to evaluate maintenance of response, safety and patient reported outcomes in acromegaly patients treated with octreotide capsules, and in patients treated with standard of care parenteral somatostatin receptor ligands (SRLs), who tolerated and demonstrated a biochemical control on both treatments.

STUDY DESIGN

Approximately 150 qualified patients with acromegaly will participate in the study through sites globally. After screening, the study will include 3 phases: 26-week run-in, 36-week randomized controlled trial, and extension phase.

At select sites, patients who do not respond according to protocol requirements to octreotide capsules during the run-in may be eligible to enter a 36- week combination phase with octreotide capsules plus cabergoline.

Patients who complete the randomized controlled phase may be permitted to enter the study extension. Find out if your patients who are currently taking somatostatin analogs may be candidates for inclusion.

For use by U.S. residents: www.MPOWEREDTrial.com

Toll-free 1-855-MPOWRED (1-855-676-9733)

MPOWERED is a phase 3, randomized, open-label, active controlled, multicenter study to evaluate maintenance of response, safety and patient reported outcomes in acromegaly patients treated with octreotide capsules, and in patients treated with standard of care parenteral somatostatin receptor ligands (SRLs), who tolerated and demonstrated a biochemical control on both treatments.

STUDY OBJECTIVES

  • To assess maintenance of biochemical control with octreotide capsules compared to parenteral SRLs in patients with acromegaly who previously demonstrated biochemical control on both treatments.
  • To assess clinical symptomatic response of octreotide capsules compared to parenteral SRLs.
  • To assess patient reported outcomes (PRO) in patients treated with octreotide capsules compared to parenteral SRLs.
  • To evaluate the safety profile of octreotide capsules compared to parenteral SRLs.
  • To assess the efficacy of octreotide capsules co- administered with cabergoline in the treatment of acromegaly patients with modestly elevated IGF-1 levels (defined as 1.3≤ IGF-1 <2 x ULN).

KEY INCLUSION CRITERIA

• Adult subjects, aged 18 to 75 years old, inclusive, at screening visit.

• Patients with acromegaly defined as documented evidence of GH-secreting pituitary tumor that is abnormally responsive to an oral glucose tolerance test or abnormal IGF-1 levels (>1 x ULN) who are currently receiving parenteral SRLs (octreotide or lanreotide but not pasireotide) for at least 6 months with a stable dose for at least the

last 4 months.

• Documented biochemical control on the current dose
of SRL (IGF-1 < 1.3 x ULN and integrated GH < 2.5 ng/mL over 2 hours), based on screening assessment.

 KEY EXCLUSION CRITERIA

• Patients taking injections of long-acting SRLs at a dosing frequency different from once monthly except for lanreotide 120 mg every 6/8 weeks.

• Symptomatic cholelithiasis.
• Received pituitary radiotherapy

within 5 years prior to screening.

• Undergone pituitary surgery within 6 months prior to screening.

• Refer to www.clinicaltrials.gov for additional entry criteria.

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