Completed
ACROINNOVA 1A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly
What is being tested
CAM2029 (octreotide subcutaneous depot)
+ Matching placebo
Drug
Who is being recruted
Acromegaly+8
+ Bone Diseases
+ Bone Diseases, Endocrine
Over 18 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: August 2019
Summary
Principal SponsorCamurus AB
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 19, 2019
Actual date on which the first participant was enrolled.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.
Official TitleA Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly
Principal SponsorCamurus AB
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
72 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
AcromegalyBone DiseasesBone Diseases, EndocrineBrain DiseasesCentral Nervous System DiseasesEndocrine System DiseasesHyperpituitarismHypothalamic DiseasesMusculoskeletal DiseasesNervous System DiseasesPituitary Diseases
Criteria
7 inclusion criteria required to participate
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
Show More Criteria
8 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalCAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.
Group II
PlaceboPlacebo (subcutaneous depot) 1.0 mL, subcutaneous injection once monthly, six months treatment. If down-titration is required, 0.5 mL dose is available.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 63 locations
Suspended
UCLA Department of Medicine Division of Endocrinology
Los Angeles, United StatesOpen UCLA Department of Medicine Division of Endocrinology in Google MapsSuspended
Stanford University Medical Center
Palo Alto, United StatesSuspended
Prufen Clinical Research LLC
Miami, United StatesSuspended
University of Michigan
Ann Arbor, United StatesCompleted63 Study Centers