Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Genentech.
NCT03060538 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 154 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (157% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
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 |
What the finished NCT03060538 record still lists
NCT03060538 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (157% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03060538 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03060538's enrollment target sits among peer trials
154 356th of 2000 higher than 1,643 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04300998 · 154 participants
Study of CAR-T Therapy in Older Patients
- NCT04597372 · 154 participants · Phase 2
Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
- NCT05294042 · 154 participants · NA
Patient Navigators for Children's Community Mental Health Services in High Poverty Urban Communities
- NCT05512390 · 154 participants · Phase 1
A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI