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Byetta 5Mcg Pen Injection for Fatty Liver (APPLE Trial)

Phase 2 & 3

Waitlist Available

Led By Melanie Cree Green, MD, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 4 months from screening visit

Awards & highlights

APPLE Trial Summary

This trial is testing if differences in how the liver processes glucose and fat may explain why women with PCOS have increased rates of hepatic steatosis, which is too much fat in the liver. The trial will enroll overweight, sedentary girls with or without PCOS.

Eligible Conditions

Fatty Liver
Polycystic Ovarian Syndrome
Obesity

APPLE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 4 months from screening visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 4 months from screening visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 4 months from screening visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hepatic glucose release

Secondary outcome measures

Hepatic Fat Fraction

Hepatic de novo lipogenesis

Hepatic phosphate concentrations

+1 more

Other outcome measures

Amino Acid Metabolomics: glutamate

Bile Acid Metabolomics: sphingosine-1-phospate

Lipid Metabolomics: 16n1

+4 more

Side effects data

From 2017 Phase 4 trial • 8 Patients • NCT02058940

38%

Death

100%

80%

60%

40%

20%

Study treatment Arm

Exenatide

APPLE Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: PCOS, medication naive + ByettaExperimental Treatment1 Intervention

PCOS, medication naive; 10 girls with PCOS will receive 2 doses of Byetta.

Group II: PCOS on COCPsActive Control1 Intervention

Up to 10 girls with PCOS and 6 months of therapy with combined oral contraceptives (COCPs) prior to study procedures.

Group III: PCOS on metforminActive Control1 Intervention

Up to 10 girls with PCOS and 6 months of therapy with metformin prior to study procedures

Group IV: ControlActive Control1 Intervention

Up to 25 girls without PCOS

Group V: PCOS medication naiveActive Control1 Intervention

Up to 45 girls with PCOS with no exposure to hormone therapy or metformin in the preceding 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Byetta 5Mcg Pen Injection

2014

Completed Phase 3

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,444 Total Patients Enrolled

7 Trials studying Fatty Liver

421 Patients Enrolled for Fatty Liver

National Center for Advancing Translational Sciences (NCATS)NIH

320 Previous Clinical Trials

401,638 Total Patients Enrolled

2 Trials studying Fatty Liver

321 Patients Enrolled for Fatty Liver

Melanie Cree Green, MD, PhDPrincipal InvestigatorDepartment of Endocrinology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study only available to seniors, or can people of all ages participate?

"The age bracket for participants in this study are individuals that have not yet turned 21 years old but are above 12."

Answered by AI

Does this scientific research mark a new development in medical treatments?

"Byetta 5Mcg Pen Injection has a long history of research dating back to 2007 when it was first trialed by CellTrans Inc. After the initial Phase 1 trial involving 21 people, Byetta 5Mcg Pen Injection received approval for Phase 3 drug trials. As of now, there are a total of 21 active Byetta 5Mcg Pen Injection trials being conducted in 11 cities and 9 countries."

Answered by AI

Are any patients currently enrolled in this clinical trial?

"This particular trial is no longer looking for participants. However, if you are interested in similar studies, there are currently 1479 trials related to fatty liver and 21 studies involving Byetta 5Mcg Pen Injection that are actively recruiting patients."

Answered by AI

Recent research and studies

Clinical EndocrinologyJournal

Clinical Prediction Score of Nonalcoholic Fatty Liver Disease in Adolescent Girls with Polycystic Ovary Syndrome (PCOS‐HS Index)

Carreau, Anne‐Marie, Laura Pyle, Yesenia Garcia‐Reyes, Haseeb Rahat, Tim Vigers, Thomas Jensen, Ann Scherzinger, Kristen J. Nadeau, and Melanie Cree‐Green. 2019. “Clinical Prediction Score of Nonalcoholic Fatty Liver Disease in Adolescent Girls with Polycystic Ovary Syndrome (PCOS‐HS Index)”. Clinical Endocrinology. Wiley. doi:10.1111/cen.14062.

The Journal of Clinical Endocrinology & MetabolismJournal

Morning Circadian Misalignment Is Associated with Insulin Resistance in Girls with Obesity and Polycystic Ovarian Syndrome

Simon, Stacey L, Laura McWhirter, Cecilia Diniz Behn, Kate M Bubar, Jill L Kaar, Laura Pyle, Haseeb Rahat, et al.. 2019. “Morning Circadian Misalignment Is Associated with Insulin Resistance in Girls with Obesity and Polycystic Ovarian Syndrome”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2018-02385.

clinicaltrials.govStudy

Liver and Fat Regulation in Overweight Adolescent Girls

2014. "Liver and Fat Regulation in Overweight Adolescent Girls". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02157974.