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NCT03060538 · ClinicalTrials.gov registry record · Phase 1
A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 154
- Enrollment target
NCT03060538 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 154 participants.
The verdict
NCT03060538, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 154 participants
- Enrollment target
Study Summary
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.
Interventions
- OTHER Placebo
- DRUG BFKB8488A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2017-03-05 |
| Est. Completion | 2019-12-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03060538
The ClinicalTrials.gov registry entry for NCT03060538 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03060538 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03060538 about?
NCT03060538 is a clinical study titled "A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease". This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAF...
What is the current status of trial NCT03060538?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 154 participants. The study started on 2017-03-05. Estimated completion is 2019-12-13.
What interventions are being tested in trial NCT03060538?
The interventions under investigation include: Placebo (OTHER), BFKB8488A (DRUG).
Who is sponsoring clinical trial NCT03060538?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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