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NCT02593331 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Otherwise Healthy Overweight and Obese Participants With Likely Insulin Resistance
A Phase 1 study of Insulin Resistance, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
- 1
- Study location
NCT02593331 is a Phase 1 study of Insulin Resistance that has completed, run by Genentech. The registered enrollment target is 79 participants, below the 245-participant average among 120 other Insulin Resistance trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02593331, a Phase 1 study of Insulin Resistance, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and tolerability profile of BFKB8488A following subcutaneous (SC) administration in overweight and obese participants (body mass index \[BMI\] greater than \[\>\] 27 to less than or equal to \[\</=\] 40 kilograms per square meter \[kg/m\^2\]) with markers of insulin resistance. Single ascending fixed doses of BFKB8488A will be evaluated. Participants will be randomized into 7 sequential ascending fixed-dose cohorts of BFKB8488A SC or placebo and safety reviews will be performed before escalation to higher dose cohorts. Additionally, following the ascending fixed-dose SC cohorts, a separate cohort will open to evaluate the PK of BFKB8488A after intravenous (IV) administration.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG BFKB8488A
Study Locations (1)
California
- Profil Institute for Clinical Research Inc. - Chula Vista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2015-10-29 |
| Est. Completion | 2017-03-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02593331
The ClinicalTrials.gov registry entry for NCT02593331 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 245-participant average among 120 other Insulin Resistance trials with a reported enrollment target (68% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Insulin Resistance appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02593331 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02593331 about?
NCT02593331 is a clinical study titled "Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Otherwise Healthy Overweight and Obese Participants With Likely Insulin Resistance". This study will evaluate the safety and tolerability profile of BFKB8488A following subcutaneous (SC) administration in overweight and obese participants (body mass index \[BMI\] greater than \[\>\] 27 to less than or equal to \[\</=\] 40 kilograms per square meter \[kg/m\^2\]) with markers of insul...
What is the current status of trial NCT02593331?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2015-10-29. Estimated completion is 2017-03-28.
What conditions does trial NCT02593331 study?
This clinical trial studies the following conditions: Insulin Resistance.
What interventions are being tested in trial NCT02593331?
The interventions under investigation include: Placebo (OTHER), BFKB8488A (DRUG).
Who is sponsoring clinical trial NCT02593331?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02593331 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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