Clinical Trial Details
| Trial ID: | L3893 |
| Source ID: | NCT03060538 |
| Associated Drug: | Bfkb8488a |
| Title: | 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 |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2|Non-Alcoholic Fatty Liver Disease |
| Interventions: | DRUG: BFKB8488A|OTHER: Placebo |
| Outcome Measures: | Primary: Percentage of Participants with Adverse Events (AE), An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution., Up to 18 weeks following first dose administration | Secondary: Serum BFKB8488A Concentration, On multiple days during treatment period and follow-up (up to 18 weeks following first dose administration)|Change from Baseline in Percentage of Participants with Anti-Therapeutic Antibodies (ATAs), Participants are considered to be ATA positive if they are ATA negative at baseline but develop an ATA response following study drug administration (treatment-induced ATA response), or if they are ATA positive at baseline and at least one post-baseline samples if above acceptable limits. The number and percentage of ATA-positive and ATA-negative participants will be summarized by treatment group., On multiple days during treatment period and follow-up (up 18 weeks following first dose administration) |
| Sponsor/Collaborators: | Sponsor: Genentech, Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 154 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2017-03-05 |
| Completion Date: | 2019-12-13 |
| Results First Posted: | |
| Last Update Posted: | 2020-03-27 |
| Locations: | Pinnacle Research Group Cullman, Anniston, Alabama, 36207, United States|Pinnacle Research Group; Llc, Central, Anniston, Alabama, 36207, United States|Southern California Research Center, Inc., Coronado, California, 92118, United States|Stanford Health Care, Stanford, California, 94305, United States|Diabetes Research Center, Tustin, California, 92780, United States|MD Clinical, Hallandale Beach, Florida, 33009, United States|Premier Research Associate, Inc, Miami, Florida, 33165, United States|Agile Clinical Research Trials, Atlanta, Georgia, 30328, United States|MidWest Clinical Research, Overland Park, Kansas, 66209, United States|Hassman Research Institute, Berlin, New Jersey, 08009, United States|Carolina Research Center at Jones Family Practice, Shelby, North Carolina, 28150, United States|New Orleans Center for Clinical Research, Knoxville, Tennessee, 37920, United States|Texas Clinical Research Institute, LLC, Arlington, Texas, 76012, United States|Dallas Diabetes & Endocrine Center, Dallas, Texas, 75230, United States|Clinical Trials of Texas Incorporated, San Antonio, Texas, 78229, United States|Northeast Clinical Research of San Antonio LLC, San Antonio, Texas, 78249, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States|inVentiv Health Clinical, Montreal, Quebec, H3X 2H9, Canada |
| URL: | https://clinicaltrials.gov/show/NCT03060538 |
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