Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly (TULIPIA)

Ipsen

Status and phase: Terminated; Phase 2

Conditions: Acromegaly

Treatments: Drug: BIM 23A760

Study type: Interventional

Funder types: Industry

Identifiers

NCT00994214

2009-010787-42 (EudraCT Number)

2-55-52060-003

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.

Enrollment: 109 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• IGF-1 ≥1.3 x upper limit normal (ULN)
• Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)
• Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.

Exclusion criteria

• The patient has received long acting somatostatin analogues within 6 months of study entry
• The patient has undergone radiotherapy at any time prior to study entry
• The time between pituitary surgery (if any) and study entry is less than 6 weeks
• The patient suffers from macroadenoma with visual field defects due to chiasmatic compression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 4 patient groups

BIM 23A760 1 mg

Experimental group

Treatment:

Drug: BIM 23A760

BIM 23A760 2 mg

Experimental group

Treatment:

Drug: BIM 23A760

BIM 23A760 4 mg

Experimental group

Treatment:

Drug: BIM 23A760

BIM 23A760 6 mg

Experimental group

Treatment:

Drug: BIM 23A760