NCT03571594 is a Phase 1 clinical trial of ONO-5788 in Acromegaly, sponsored by Ono Pharmaceutical Co., Ltd..

Who is sponsoring NCT03571594?

NCT03571594 is sponsored by Ono Pharmaceutical Co., Ltd..

What drugs are being tested in NCT03571594?

Interventions in NCT03571594: ONO-5788, ONO-5788 Placebo, Octreotide.

What condition does NCT03571594 study?

NCT03571594 studies Acromegaly.

Is NCT03571594 still recruiting?

NCT03571594 is currently terminated. Last updated 5 June 2019.

Last reviewed 2019-06-05 · How we verify

NCT03571594

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers

Terminated Phase 1 Last updated 5 June 2019

What this trial tests

Phase 1 trial testing ONO-5788 in Acromegaly in 76 participants. Terminated before completion.

Timeline

7 June 2018

Primary endpoint
16 May 2019

16 May 2019

Quick facts

Lead sponsor	Ono Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	76
Start date	7 June 2018
Primary completion	16 May 2019
Estimated completion	16 May 2019
Sites	1 location across United States

Drugs / interventions tested

ONO-5788 — full drug profile →
ONO-5788 Placebo
Octreotide (OCTREOTIDE) — full drug profile →

Conditions studied

Acromegaly — all drugs for Acromegaly →

Sponsor

Ono Pharmaceutical Co., Ltd.

Who can join

18 and older, any sex, with Acromegaly. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

The Future of Somatostatin Receptor Ligands in Acromegaly.
Gadelha MR, Wildemberg LE, Kasuki L. · · 2022 · cited 59× · PMID 34618894 · DOI 10.1210/clinem/dgab726
Differential Impact of Medical Therapies for Acromegaly on Glucose Metabolism.
Gatto F, Arecco A, Amarù J, Arvigo M, et al · · 2025 · cited 3× · PMID 39859181 · DOI 10.3390/ijms26020465
Clinical Management of Acromegaly: Therapeutic Frontiers and New Perspectives for Somatostatin Receptor Ligands (SRLs).
Brunetti A, Antonini S, Saladino A, Lavezzi E, et al · · 2022 · cited 2× · PMID 35744057 · DOI 10.3390/medicina58060794

Verify or expand the search:

Other trials of ONO-5788

Trials testing the same drug.

NCT03849872 — Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788 · Phase 1 · completed

Other recruiting trials for Acromegaly

Currently open trials in the same condition.

NCT07037420 — ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly · Phase 2 · recruiting
NCT05401084 — Diet in the Management of Acromegaly · NA · recruiting
NCT05131100 — Korean Regulatory Post Marketing Surveillance for Somavert · recruiting
NCT05964712 — Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study · recruiting
NCT03158090 — The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research · recruiting

Other Ono Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07169708 — A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable · not yet recruiting
NCT06936943 — ONO-4538 Study in Patients With Richter's Transformation · Phase 2 · recruiting
NCT06948448 — A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 an · Phase 2 · recruiting
NCT07198087 — A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impa · Phase 1 · active not recruiting
NCT06803823 — A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03571594 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ono Pharmaceutical Co., Ltd.
Last refreshed: 5 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03571594.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing