CAM2029 for Acromegaly

Recruiting at 68 trial locations

Overseen By Camurus AB

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Camurus AB

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 52 weeks

135 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the long-term safety and effectiveness of CAM2029, an injection given regularly, in patients with acromegaly. The medication helps to manage symptoms by reducing growth hormone levels. Patients from a previous related trial can continue treatment, and those completing the main trial can extend their treatment for an additional period.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of octreotide LAR or lanreotide ATG for at least 3 months before joining. If you are taking other medications for acromegaly, like pasireotide, pegvisomant, or dopamine agonists, you must stop them before the trial, with specific timeframes mentioned for each.

Is CAM2029 safe for humans?

Research shows that CAM2029, a liquid crystal octreotide depot, has a favorable safety profile in clinical trials for acromegaly, meaning it is generally safe for humans. ^{1 2 3 4 5}

How does the drug CAM2029 differ from other treatments for acromegaly?

CAM2029 is a somatostatin analog, similar to other treatments like octreotide, but it may offer a unique formulation or administration method that could improve patient convenience or effectiveness. Somatostatin analogs work by mimicking a natural hormone that inhibits growth hormone release, which is crucial in managing acromegaly. ^{6 7 8 9 10}

Research Team

Diego Ferone, Dr

Principal Investigator

University of Genova Endocrinology Unit

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with acromegaly.

I have been on a stable dose of octreotide or lanreotide for at least 3 months.

Your IGF-1 levels are too high or too low.

Exclusion Criteria

I have not had major surgery in the last month.

I need surgery for vision problems due to pressure on my optic nerve.

I had pituitary surgery within the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients are administered CAM2029 subcutaneously once monthly for 12 months

52 weeks

12 visits (in-person)

Open-label extension

Participants completing the main part of the trial are offered 52 weeks continued open-label treatment

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CAM2029

Trial Overview 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.

Participant Groups

Group I: CAM2029 (octreotide subcutaneous depot) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Camurus AB

Lead Sponsor

Trials

9

Recruited

1,900+

References

1. England pubmed.ncbi.nlm.nih.gov

Disease activity and lifestyle influence comorbidities and cardiovascular events in patients with acromegaly. [2022]

2. England pubmed.ncbi.nlm.nih.gov

New therapeutic agents for acromegaly. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Long-term treatment of acromegaly with the somatostatin analogue SR-lanreotide. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of long-acting pasireotide in acromegaly. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacological approach to the treatment of acromegaly. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Effect of repeated injections of sandostatine, with increasing doses, in the treatment of 40 acromegalics. French Group for the study of Sandostatine in Acromegaly]. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Current and Emerging Aspects of Diabetes Mellitus in Acromegaly. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Dissecting the In Vitro Efficacy of Octreotide and Cabergoline in GH- and GH/PRL-Secreting Pituitary Tumors. [2023]

10. Scotland pubmed.ncbi.nlm.nih.gov

Growth hormone receptor antagonist improves insulin resistance in acromegaly. [2019]