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COMPLETED Phase 1

Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects

NCT00555451 · View on ClinicalTrials.gov ↗

Study Summary

The objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of HE3286 when administered daily for 28 days to obese adult subjects and to assess potential activity of HE3286 to decrease insulin resistance. An open-label cohort of 6 patients with type II diabetes mellitus will be treated at 10 mg (5 mg BID).

Conditions Studied

Interventions

  • DRUG HE3286

Study Locations (2)

Louisiana

  • — Baton Rouge

Texas

  • dgd Research, Inc. — San Antonio

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2007-10
Est. Completion 2009-09
Phase Phase 1

Sponsor

Harbor Therapeutics

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00555451

The ClinicalTrials.gov registry entry for NCT00555451 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Harbor Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Insulin Resistance appearing as the primary indexed condition, and to 1 intervention — of which HE3286 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00555451 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Louisiana, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00555451 about?

NCT00555451 is a clinical study titled "Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects". The objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of HE3286 when administered daily for 28 days to obese adult subjects and to assess potential activity of HE3286 to decrease insulin resistance. An open-label cohort of 6 patients with type II diabetes mellitus w...

What is the current status of trial NCT00555451?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2007-10. Estimated completion is 2009-09.

What conditions does trial NCT00555451 study?

This clinical trial studies the following conditions: Insulin Resistance. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00555451?

The interventions under investigation include: HE3286 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00555451?

This trial is sponsored by Harbor Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00555451 being conducted?

This trial has 2 study locations across Louisiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial