What side effects are associated with this type of intervention?

Somatostatin analogs, such as octreotide and lanreotide, which are used to treat acromegaly by inhibiting growth hormone release, are associated with several side effects. Common adverse effects include gastrointestinal symptoms like nausea, vomiting, diarrhea, and abdominal pain. Patients may also experience gallbladder issues, such as gallstones. Additionally, there can be metabolic disturbances, including hyperglycemia and, less frequently, diabetes. Injection site reactions and fatigue are also reported. While these medications are effective in controlling hormone levels, monitoring for these side effects is essential for optimal patient management.

What prior FDA approvals exist?

The FDA has approved several somatostatin analogs for the treatment of acromegaly, which work by inhibiting the release of growth hormone. Notable drugs in this category include octreotide (Sandostatin) and lanreotide (Somatuline Depot). These medications are administered via injection and have been shown to effectively reduce growth hormone and insulin-like growth factor-1 (IGF-1) levels in patients with acromegaly. Pasireotide (Signifor) is another somatostatin analog approved for patients who do not respond adequately to other treatments. These drugs are similar to CAM2029, which is being studied for its long-term safety and efficacy in acromegaly treatment.

What other types of research exist?

Promising novel alternatives to CAM2029 for acromegaly patients include other somatostatin analogs like octreotide and lanreotide, as well as newer therapies such as pasireotide, which has shown efficacy in patients not responding to first-generation somatostatin analogs. Additionally, growth hormone receptor antagonists like pegvisomant and dopamine agonists like cabergoline are also considered effective alternatives.

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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

Must not have

Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated for New Patients

Unresolved, drug-related serious adverse event (SAE) from the preceding trial for Roll-over Patients from NCT04076462

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0-52

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have ongoing serious side effects from a previous trial (NCT04076462).

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I have had pituitary gland radiation within the last 3 years.

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My diabetes is not well-managed (A1c > 8.0%).

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I take octreotide or lanreotide less often than every 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0-52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0-52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0-52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Proportion of patients/partners declared competent by a healthcare professional to administer intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Somatostatin analogs, such as octreotide and lanreotide, are common treatments for Acromegaly that work by inhibiting the release of growth hormone (GH) from the pituitary gland. This is significant for Acromegaly patients because excessive GH leads to abnormal growth of tissues and organs, causing symptoms like enlarged hands and feet, facial changes, and various systemic complications. By reducing GH levels, somatostatin analogs help manage these symptoms and prevent further complications, improving the quality of life for patients.