NCT00519727 is a Phase 1 clinical trial of ISIS 325568 in Type 2 Diabetes Mellitus, sponsored by Ionis Pharmaceuticals, Inc..

Who is sponsoring NCT00519727?

NCT00519727 is sponsored by Ionis Pharmaceuticals, Inc..

What drugs are being tested in NCT00519727?

Interventions in NCT00519727: ISIS 325568.

What condition does NCT00519727 study?

NCT00519727 studies Type 2 Diabetes Mellitus.

Is NCT00519727 still recruiting?

NCT00519727 is currently completed. Last updated 15 August 2008.

Last reviewed 2008-08-15 · How we verify

NCT00519727

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

A Phase I, Double-Blind, Placebo-Controlled, Dose- Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 325568 Administered to Healthy Volunteers

Completed Phase 1 Last updated 15 August 2008

What this trial tests

Phase 1 trial testing ISIS 325568 in Type 2 Diabetes Mellitus in 60 participants. Completed in 1 June 2008.

Timeline

1 August 2007

Primary endpoint
1 April 2008

1 June 2008

Quick facts

Lead sponsor	Ionis Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 August 2007
Primary completion	1 April 2008
Estimated completion	1 June 2008
Sites	1 location across Netherlands

Drugs / interventions tested

ISIS 325568 — full drug profile →

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Ionis Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Type 2 Diabetes Mellitus. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

safety and tolerability
Time frame: 30 days for single dose, 16 weeks for multi-dose

Sponsor's own description

The primary purpose of this trial is to assess the safety of ISIS 325568 when given at increasing single doses and to assess the safety of the same doses when given multiple times.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Early-Stage Identification and Avoidance of Antisense Oligonucleotides Causing Species-Specific Inflammatory Responses in Human Volunteer Peripheral Blood Mononuclear Cells.
Burel SA, Machemer T, Baker BF, Kwoh TJ, et al · · 2022 · cited 15× · PMID 35976085 · DOI 10.1089/nat.2022.0033

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Ionis Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT06673069 — Hero: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) and Pharmacodynamics (PD) of ION269 in Par · Phase 1 · terminated
NCT06014541 — Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG Binding Protein 2 · terminated
NCT05610280 — A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, · Phase 3 · completed
NCT05579860 — A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healt · Phase 1 · completed
NCT05552326 — A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia · Phase 3 · completed

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 NCT00519727 (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 Ionis Pharmaceuticals, Inc.
Last refreshed: 15 August 2008

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/NCT00519727.

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