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Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

NCT07087054 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2026-04-30

No results posted yet for this study

Summary

A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.

Conditions

  • Carcinoid Syndrome
  • Carcinoid
  • Carcinoid Tumor
  • Carcinoid Tumor of Ileum
  • Carcinoid Tumor of Cecum
  • Carcinoid Tumor of Liver
  • Carcinoid Tumor of Pancreas
  • Carcinoid Syndrome Diarrhea
  • Carcinoid Intestine Tumor

Interventions

DRUG

Paltusotine

Experimental Drug: Randomized

DRUG

Placebo

Matching Placebo Drug: Randomized

Sponsors & Collaborators

  • Crinetics Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-19
Primary Completion
2027-08-31
Completion
2030-01-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • Colombia
  • France
  • Mexico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07087054 on ClinicalTrials.gov