NCT04018339 is a Phase 1 clinical trial of Bardoxolone methyl in Obese Adult Male, sponsored by Kyowa Kirin Co., Ltd..

Who is sponsoring NCT04018339?

NCT04018339 is sponsored by Kyowa Kirin Co., Ltd..

What drugs are being tested in NCT04018339?

Interventions in NCT04018339: Bardoxolone methyl, Placebo.

What condition does NCT04018339 study?

NCT04018339 studies Obese Adult Male.

Is NCT04018339 still recruiting?

NCT04018339 is currently completed. Last updated 23 June 2020.

Last reviewed 2020-06-23 · How we verify

NCT04018339

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

A Study of RTA 402 in Obese Adults

Completed Phase 1 Last updated 23 June 2020

What this trial tests

Phase 1 trial testing Bardoxolone methyl in Obese Adult Male in 22 participants. Completed in 18 June 2020.

Timeline

20 August 2019

Primary endpoint
28 May 2020

18 June 2020

Quick facts

Lead sponsor	Kyowa Kirin Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	22
Start date	20 August 2019
Primary completion	28 May 2020
Estimated completion	18 June 2020
Sites	1 location across Japan

Drugs / interventions tested

Bardoxolone methyl — full drug profile →
Placebo

Conditions studied

Obese Adult Male — all drugs for Obese Adult Male →

Sponsor

Kyowa Kirin Co., Ltd. — full company profile →

Who can join

Adults 20 to 49, male only, with Obese Adult Male. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To investigate changes in body weight and body composition in obese adults after repeated oral administration of RTA 402 once daily for 16 weeks, using placebo as a control.

Publications & conference data

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

Recent Advances in Understanding Nrf2 Agonism and Its Potential Clinical Application to Metabolic and Inflammatory Diseases.
Kim MJ, Jeon JH. · · 2022 · cited 60× · PMID 35269986 · DOI 10.3390/ijms23052846
The Emerging Therapeutic Potential of Nitro Fatty Acids and Other Michael Acceptor-Containing Drugs for the Treatment of Inflammation and Cancer.
Piesche M, Roos J, Kühn B, Fettel J, et al · · 2020 · cited 26× · PMID 33013366 · DOI 10.3389/fphar.2020.01297

Verify or expand the search:

Other trials of Bardoxolone methyl

Trials testing the same drug.

NCT04023903 — A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults · Phase 1 · completed
NCT03749447 — An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) · Phase 3 · terminated
NCT03550443 — A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study · Phase 3 · terminated
NCT03068130 — Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER · Phase 3 · terminated
NCT02036970 — Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT · Phase 2 · completed

Other Kyowa Kirin Co., Ltd. trials

Trials by the same sponsor.

NCT06926491 — Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study） · Phase 3 · recruiting
NCT06812104 — Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
NCT06525636 — A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia · Phase 1, PHASE2 · recruiting
NCT06116890 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration · Phase 2 · active not recruiting
NCT06116916 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema · Phase 2 · active not 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 NCT04018339 (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 Kyowa Kirin Co., Ltd.
Last refreshed: 23 June 2020

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/NCT04018339.

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