Paltusotine for Acromegaly

(PATHFNDR-2 Trial)

Recruiting at 78 trial locations

Overseen By Crinetics Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Crinetics Pharmaceuticals Inc.

Must not be taking: Pegvisomant, Cabergoline, Pasireotide

Disqualifiers: Malignancy, HIV, Hepatitis, Alcohol abuse, others

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: Unknown

Duration: 24 weeks

111 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new pill called paltusotine for people with acromegaly who haven't tried other treatments. The pill works by lowering growth hormone levels in the body.

Will I have to stop taking my current medications?

The trial requires participants to either be medically naïve, not currently treated, or willing to stop their current medications during the study screening period. If you are on certain medications, you may need to stop taking them to participate.

What data supports the effectiveness of the drug Paltusotine for treating acromegaly?

Research shows that Paltusotine, an oral drug, can lower levels of growth hormone and IGF-1, which are often high in people with acromegaly. This suggests it may help manage the condition effectively. ^{1 2 3 4 5}

Is Paltusotine safe for humans?

Paltusotine has been studied for safety in healthy volunteers and patients with acromegaly, showing it is generally safe for human use. It is an oral medication being developed to treat acromegaly and neuroendocrine tumors, and no major safety concerns have been reported in the studies available. ^{1 2 6 7 8}

How is the drug Paltusotine different from other treatments for acromegaly?

Paltusotine is unique because it is an oral medication taken once daily, unlike many other treatments for acromegaly that require injections. It works by targeting the somatostatin receptor subtype 2 (SST2) to suppress growth hormone (GH) and insulin-like growth factor 1 (IGF-1) levels, which are often elevated in acromegaly. ^{1 2 6 9 10}

Eligibility Criteria

This trial is for adults over 18 with acromegaly who haven't been treated pharmacologically or are willing to stop current treatments during the study. Participants must not be pregnant, should use birth control if necessary, and cannot have had certain cancer treatments or suffer from specific heart conditions.

Inclusion Criteria

I have acromegaly and am either not on treatment or willing to stop my current treatment for the study.

I have acromegaly and am either not on treatment or willing to stop my current treatment for the study.

I am not pregnant or breastfeeding, and I am either unable to have children, past menopause, or using birth control.

Exclusion Criteria

I have not had pituitary radiation therapy in the last 3 years.

Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer

I have heart conditions or take medications that affect my heart rhythm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either paltusotine or placebo for the treatment of acromegaly

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Paltusotine

Trial Overview The trial is testing Paltusotine's safety and effectiveness compared to a placebo in treating acromegaly. It's a randomized study where participants will either receive the actual drug or a placebo without knowing which one they're getting.

Participant Groups

Group I: Paltusotine Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Crinetics Pharmaceuticals Inc.

Lead Sponsor

Trials

13

Recruited

760+

References

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

ACROBAT Edge: Safety and Efficacy of Switching Injected SRLs to Oral Paltusotine in Patients With Acromegaly. [2023]

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

Paltusotine, a novel oral once-daily nonpeptide SST2 receptor agonist, suppresses GH and IGF-1 in healthy volunteers. [2022]

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

Cabergoline therapy of growth hormone & growth hormone/prolactin secreting pituitary tumors. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[Optimization of the medical treatment for acromegaly]. [2018]

5. Egypt pubmed.ncbi.nlm.nih.gov

Medical therapy of acromegaly. [2021]

6. Italy pubmed.ncbi.nlm.nih.gov

Current status and future directions of pharmacological therapy for acromegaly. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Treatment strategies for acromegaly. [2018]

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

Treatment of acromegaly: is there still a place for radiotherapy? [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Treatment of acromegaly with bromocryptine. [2019]

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

Pharmacological management of acromegaly: a current perspective. [2022]