CAM2029 for Acromegaly

No longer recruiting at 95 trial locations

Overseen By Camurus AB

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Camurus AB

Must be taking: Octreotide, Lanreotide

Must not be taking: Pasireotide, Pegvisomant, Dopamine agonists

Disqualifiers: Unstable condition, Major surgery, Diabetes, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the long-term safety and effectiveness of a new treatment called CAM2029 for individuals with acromegaly, a condition characterized by excessive growth hormone production. Participants will receive a monthly injection of CAM2029 for one year, with an option for extended treatment. The study seeks individuals diagnosed with acromegaly who have maintained a stable dose of specific medications for at least three months. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

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 there any evidence suggesting that CAM2029 is likely to be safe for humans?

Research has shown that CAM2029 is generally safe for people with acromegaly. Studies have found it safe for most users, and over a year of treatment, CAM2029 proved safe in the long term. This indicates its safety even with year-long use.

CAM2029 offers a convenient and effective treatment option, requiring only one monthly injection under the skin. This method is not only effective but also more comfortable for patients compared to other treatments. Overall, evidence suggests that CAM2029 is a safe option for treating acromegaly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acromegaly?

Researchers are excited about CAM2029 because it offers a new way to manage acromegaly with a convenient delivery method. Unlike traditional somatostatin analogs that often require daily injections, CAM2029 is a long-acting octreotide subcutaneous depot that only needs to be administered once a month. This can greatly improve patient comfort and compliance. Plus, its sustained release formula aims to maintain stable drug levels, potentially providing better symptom control with fewer side effects.

What evidence suggests that CAM2029 might be an effective treatment for acromegaly?

Research has shown that CAM2029, which participants in this trial will receive, effectively treats acromegaly. Studies have found that monthly injections of CAM2029 significantly improve levels of IGF-1, a key indicator of acromegaly. The treatment is considered safe and has been reported to enhance patients' perceptions of their health. CAM2029, a type of octreotide injected under the skin, helps the body use it more effectively. Overall, long-term research supports CAM2029 as a promising new treatment for acromegaly, with a safety profile similar to standard treatments. ^{3 4 5 6 7}

Who Is on the Research Team?

Diego Ferone, Dr

Principal Investigator

University of Genova Endocrinology Unit

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12546529/

SUN-097 CAM2029 Octreotide Subcutaneous Depot ... These data inform on the efficacy profile of CAM2029 when administration occurs both within and beyond a 28-day dosing window. Presentation ...

2. academic.oup.com academic.oup.com/jcem/article/110/6/1729/7815757

A Randomized, Double-blind, Placebo-controlled Phase 3 ... CAM2029, a novel subcutaneous octreotide depot with increased bioavailability using FluidCrystal technology, enables self-administration and room-temperature ...

3. healio.com healio.com/news/endocrinology/20250714/oncemonthly-octreotide-for-acromegaly-safe-effective-improves-patientreported-outcomes

Once-monthly octreotide safe, improves acromegaly ... Once-monthly octreotide for acromegaly safe, effective, improves patient-reported outcomes · Key takeaways: · IGF-1 levels improved · High ...

4. endocrine-abstracts.org endocrine-abstracts.org/ea/0110/ea0110rc4.4

Results from the core phase of the ... These long-term findings support CAM2029 as an effective new treatment for acromegaly with a safety profile consistent with SoC.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04125836

NCT04125836 | A Trial to Assess the Long-term Safety of ... The purpose of this trial is to assess the long-term safety and efficacy of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39378125/

A Randomized, Double-blind, Placebo-controlled Phase 3 ... Results: At week 22/24 (intention-to-treat analysis), CAM2029-treated patients demonstrated superior response rates vs placebo for IGF-1 (72.2% ...

7. camurus.com camurus.com/media/press-releases/2023/camurus-announces-new-phase-3-data-reinforcing-long-term-safety-and-efficacy-of-octreotide-sc-depot-cam2029-in-patients-with-acromegaly/

Camurus announces new Phase 3 data reinforcing long- ... The Phase 3 data show a favorable safety profile and robust long-term efficacy over 52 weeks of treatment with CAM2029.