Acromegaly Combination Treatment Study

The study will begin when the combination of Sandostatin LAR or Somatuline and pegvisomant is
first administered. Study visits will occur every 4 weeks from the start of the study.
However, for subjects who cannot make every study visit due to distance, the study team will
facilitate monthly blood draws at their local Quest laboratory facility.

After the 24 weeks of combination therapy, subjects with a controlled IGF-1 will then start
Pegvisomant monotherapy at the same dose that they attained normalization in combination
therapy. IGF-1 levels, liver function test, and blood glucose will be performed monthly. An
MRI will be performed at the conclusion of the 48 week treatment period.

Inclusion Criteria:

- Newly diagnosed patients with acromegaly who have not had surgery or medical therapy

- Acromegaly patients who are at least 3 months post surgery, who are/are not receiving
adjuvant medical therapy

- Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels

- Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels.

- Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week
washout period of the dopamine agonist.

- Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant
(daily or weekly

- Normal liver function tests before randomization to treatment

- The patient has had appropriate dynamic testing of the pituitary axis and, if
applicable, is receiving appropriate hormone replacement therapy.

Exclusion Criteria:

- The patient harbors a macroadenoma with visual field defects due to chiasmatic
compression

- The patient has clinically significant hepatic abnormalities and/or aspartate
aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper
limit of normal at the baseline visit.

- The patient had pituitary surgery within 3 months prior to study entry

- The patient had radiotherapy within 12 months prior to study entry

- The patient has abnormal CBC and chemistry panel at the baseline visit, any other
medical condition(s) or laboratory findings that, in the opinion of the investigator,
might jeopardize the patient's safety.

- The patient has a known hypersensitivity to any of the test materials or related
compounds.

- The patient has a history of, or known current problems with alcohol or drug abuse.

- The patient has any mental condition rendering the patient unable to understand the
nature, scope, and possible consequences of the study, and/or evidence of an
uncooperative attitude.