Acromegaly
Conditions
Keywords
Acromegaly, octreotide, CAM2029, phase 3
Brief summary
The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.
Interventions
Octreotide subcutaneous depot for monthly injections in acromegaly patients
DRUGMatching placebo
Matching placebo for CAM2029
Sponsors
Camurus AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients, ≥18 years at screening * Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed * Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly * Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening * IGF-1 levels ≤1xULN at screening * Adequate liver, pancreatic, renal and bone marrow functions * Normal ECG
Exclusion criteria
* GH ≥2.5 μg/L at screening (cycle) * Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening \[whichever is longer\] * Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks) * Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated * Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening * Patients who have undergone pituitary surgery within 6 months prior to screening * Patients who have received prior pituitary irradiation * Patients with poorly controlled diabetes mellitus (hemoglobin A1c \>8.0%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with mean IGF-1 levels ≤1xULN | Week 22 and 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with mean IGF-1 levels ≤1xULN at Week 22/Week 24 and mean GH levels <2.5 µg/L at Week 24 | Week 22 and 24 | — |
| Proportion of patients with mean GH levels <2.5 µg/L | Week 24 | — |
| Proportion of patients with mean GH levels <1.0 µg/L | Week 24 | — |
| Proportion of patients with mean IGF-1 levels ≤1xULN, including patients with dose reduction | Week 22 and 24 | — |
| Proportion of patients/partners declared competent by a healthcare professional to administer intervention | Week 0 to 20 and week 24 | During patients/partners first three attempts during the trial period of 24 weeks whenever these visits take place |
| Octreotide plasma concentrations over time | Week 0 to 24 | — |
| Incidence of treatment emergent adverse events | Week 0 to 24 | — |
Countries
Germany, Greece, Hungary, Italy, Poland, Russia, Spain, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed