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TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas

NCT04335357 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-04-06

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks.

Conditions

  • Non-Functional Pituitary Adenoma
  • Pituitary Tumor, Nonfunctioning

Interventions

DRUG

TBR-760

TBR-760 is intended for SC administration. The target dose to be studied in this study is 6 mg SC given once weekly.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Tiburio Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2023-03-31
Completion
2023-06-30
FDA Drug
Yes

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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 NCT04335357 on ClinicalTrials.gov