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Somatostatin Analog

CAM2029 for Acromegaly

Phase 3
Waitlist Available
Led By Diego Ferone, M.D
Research Sponsored by Camurus AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 50 to 52
Awards & highlights

Study Summary

This trial is testing the long-term safety of a drug called CAM2029 in patients with a condition called acromegaly. Patients will get the drug once a month for 12 months, and then may be able to keep getting it for another year.

Who is the study for?
Adults diagnosed with acromegaly who have been on a stable dose of octreotide LAR or lanreotide ATG for at least 3 months can join. They must have certain levels of IGF-1, good organ function, and a normal ECG. People who've had recent surgery, uncontrolled diabetes, or used specific acromegaly treatments recently cannot participate.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of CAM2029 (octreotide subcutaneous depot) in treating acromegaly. Participants will receive monthly injections for up to one year. Those from an earlier trial may continue treatment here.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, gastrointestinal issues like diarrhea or stomach pain, gallstones, changes in blood sugar levels, fatigue and headache. Long-term effects are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with acromegaly.
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I have been on a stable dose of octreotide or lanreotide for at least 3 months.
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I am 18 years old or older.
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My liver, kidneys, pancreas, and bone marrow are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 50 to 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 50 to 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Characterization of adverse events (AEs)
Secondary outcome measures
Octreotide plasma concentrations over time
Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L
Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CAM2029 (octreotide subcutaneous depot)Experimental Treatment1 Intervention
CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment with an option of extension. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAM2029 (octreotide subcutaneous depot)
2019
Completed Phase 3
~80

Find a Location

Who is running the clinical trial?

Camurus ABLead Sponsor
8 Previous Clinical Trials
1,727 Total Patients Enrolled
2 Trials studying Acromegaly
84 Patients Enrolled for Acromegaly
Diego Ferone, M.DPrincipal InvestigatorUniversity of Genova Endocrinology Unit

Media Library

CAM2029 (Somatostatin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04125836 — Phase 3
Acromegaly Research Study Groups: CAM2029 (octreotide subcutaneous depot)
Acromegaly Clinical Trial 2023: CAM2029 Highlights & Side Effects. Trial Name: NCT04125836 — Phase 3
CAM2029 (Somatostatin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04125836 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other ongoing or completed research studies that have used CAM2029 (octreotide subcutaneous depot)?

"CAM2029 (octreotide subcutaneous depot) was first studied in 1997 at Vanderbilt University Autonomic Dysfunction Center. Since the initial study, 105 more have been completed with 16 presently active and recruiting patients. The majority of these studies are based out of Missouri's largest city, Saint Louis."

Answered by AI

For what purpose is CAM2029 (octreotide subcutaneous depot) most often prescribed?

"octreotide is frequently treated with CAM2029 (octreotide subcutaneous depot). Other conditions that this medication can help manage include long-term maintenance therapy, acromegaly, and metastatic carcinoid tumors."

Answered by AI

At how many different test sites is this research being conducted?

"There are 11 sites enrolling patients for this clinical trial, which include locations such as Saint Louis, Los Angeles and Cincinnati. To reduce the burden of travel on participants, it is best to select a location closest to you."

Answered by AI

Has CAM2029 (octreotide subcutaneous depot) received FDA approval?

"CAM2029 (octreotide subcutaneous depot) has been given a safety rating of 3. This is based on the fact that it is currently in Phase 3 clinical trials, meaning that there is both evidence of efficacy and multiple rounds data supporting its safety."

Answered by AI

Does this experiment still need more test subjects?

"This information can be found on clinicaltrials.gov; the study is still recruiting patients and was first posted on 10/10/2019 with a most recent edit on 9/1/2022."

Answered by AI
~28 spots leftby Jun 2025