NCT03842761 is a Phase 1 clinical trial of BI 685509 in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT03842761?

NCT03842761 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT03842761?

Interventions in NCT03842761: BI 685509, Placebo.

What condition does NCT03842761 study?

NCT03842761 studies Healthy, Hepatic Insufficiency.

Is NCT03842761 still recruiting?

NCT03842761 is currently completed. Last updated 10 June 2021.

Last reviewed 2021-06-10 · How we verify

NCT03842761

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

A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems

Completed Phase 1 Last updated 10 June 2021

What this trial tests

Phase 1 trial testing BI 685509 in Healthy in 64 participants. Completed in 20 May 2021.

Timeline

6 March 2019

Primary endpoint
9 April 2021

20 May 2021

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	6 March 2019
Primary completion	9 April 2021
Estimated completion	20 May 2021
Sites	1 location across United States

Drugs / interventions tested

BI 685509 — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →
Hepatic Insufficiency — all drugs for Hepatic Insufficiency →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Healthy or Hepatic Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment \[Child-Turcotte-Pugh (CTP) classification A and B\] over different dose regimes of BI 685509 compared to placebo. A secondary objective is to investigate pharmacokinetics of different doses of BI 685509 in patients with mild to moderate hepatic impairment (CTP A and CTP B). In addition, another secondary objective is to compare safety, tolerability, and pharmacokinetics in patients with mild to moderate hepatic impairment (CTP A and CTP B) of single BI 685509 dose to individually matched healthy volunteers

Publications & conference data

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

Safety and pharmacokinetics of BI 685509, a soluble guanylyl cyclase activator, in patients with cirrhosis: A randomized Phase Ib study.
Lawitz EJ, Lawitz EJ, Reiberger T, Schattenberg JM, et al · · 2023 · cited 10× · PMID 37889522 · DOI 10.1097/hc9.0000000000000276
Inter-organ metabolic interaction networks in non-alcoholic fatty liver disease.
Fan YH, Zhang S, Wang Y, Wang H, et al · · 2024 · cited 8× · PMID 39850476 · DOI 10.3389/fendo.2024.1494560
From Pathophysiology to Practice: Evolving Pharmacological Therapies, Clinical Complications, and Pharmacogenetic Considerations in Portal Hypertension.
Porada M, Bułdak Ł. · · 2025 · cited 5× · PMID 39997697 · DOI 10.3390/metabo15020072
Hepatic improvement within 27 days of avenciguat treatment in Child-Pugh A cirrhosis detected by an oral cholate challenge test.
Lawitz EJ, Ertle J, Schoelch C, Gashaw I, et al · · 2024 · cited 4× · PMID 38869987 · DOI 10.1097/lvt.0000000000000420
Safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509, a soluble guanylyl cyclase activator, in healthy volunteers: Results from two randomized controlled trials.
Wong D, Seitz F, Bauer V, Giessmann T, et al · · 2024 · cited 4× · PMID 38789635 · DOI 10.1007/s00210-024-03165-w

Verify or expand the search:

Other trials of BI 685509

Trials testing the same drug.

NCT04750577 — A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease · Phase 2 · completed
NCT03165227 — This Study Tests a New Medicine Called BI 685509 in Patients That Have Kidney Problems Because of Diabetes. The Study Te · Phase 1 · completed
NCT03259464 — This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Tak · Phase 1 · completed
NCT03116906 — Safety and Tolerability of BI 685509 in Healthy Subjects · Phase 1 · completed

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet 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 NCT03842761 (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 Boehringer Ingelheim
Last refreshed: 10 June 2021

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/NCT03842761.

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