Number of Patients With Improvement in Liver Histology After Treatment With Exenatide
| Group | Value (participants) |
|---|---|
| Treatment With Exenatide | 8 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataShort name NAFLD
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven NASH.
Experimental
A pre treatment NAS score
liver biopsy score pre treatment with exenatide 5 micrograms SQ (sub-cutaneous) twice a day titrated to 10 mcg SQ twice a day as tolerated
Outcomes the sponsor listed as primary.
Number of Patients With Improvement in Liver Histology After Treatment With Exenatide
Time frame · between baseline and 24-28 weeks after initiating treatment
Number of patients with liver histology improved with exenatide. The improvement of liver histology was defined as (1) no worsening of the fibrosis score, (11) improved score by at least one point in hepatocyte ballooning, and (111) either (a) improvement in NAS (NAFLD Activity Score) by two points spread across as least two of the three NAS components, or by (B)post-treatment NAS\<3.
Change in NAS
Time frame · Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq.
The NAFLD Activity Score (NAS) is an underweight sum of steatosis (score 0-3), inflammation (score 0-3), ballooning scores (0-2). The NAS can range from 0-8 with the higher score indicating more aggressive disease.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| Treatment With Exenatide | 8 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Individuals Who Recieved Treatment With Exenatide | -1.5 | 1.66 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide GroupExenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day | – | 0 / 8 | 2 / 8 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Clinical trial · 2003
Kolterman et al. 2003The Journal of clinical endocrinology and metabolismcited by 389
PMID 12843147DOI 10.1210/jc.2002-021545PUB-12843147
Indexing hint: Animal study · 1999
Greig et al. 1999Diabetologiacited by 150
PMID 10027577DOI 10.1007/s001250051111PUB-10027577
1 study on this page
Indexing hint: Observational study · 1990
Eng et al. 1990The Journal of biological chemistrycited by 48
PMID 1700785DOI 10.1016/s0021-9258(17)30498-2PUB-01700785
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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