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GLP-1 Receptor Antagonist

Exendin (9-39) for Low Blood Sugar After Bariatric Surgery

Phase 1
Waitlist Available
Research Sponsored by Tracey McLaughlin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery
Men and women ages 18-65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-180 minutes
Awards & highlights

Study Summary

This trial will test whether GLP-1 is the cause of hypoglycemia in a subset of bariatric surgery patients.

Who is the study for?
This trial is for men and women aged 18-65 with a BMI of 25-40 who have severe low blood sugar after bariatric surgery. It's not for those pregnant, on certain medications, or with conditions like heart failure, kidney or liver issues, COPD, anemia, uncontrolled high blood pressure, or active psychiatric diseases.Check my eligibility
What is being tested?
The study tests the effect of a drug called Exendin (9-39) versus a placebo on patients experiencing extreme drops in blood sugar levels following bariatric surgery. The goal is to understand if GLP-1 plays a role in these hypoglycemic episodes.See study design
What are the potential side effects?
While specific side effects are not listed here, common reactions to drugs similar to Exendin (9-39) may include nausea, vomiting, diarrhea and potential allergic reactions. Placebo typically has no side effects but can cause symptoms due to psychological factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 25-40 and I have severe low blood sugar episodes after weight-loss surgery.
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-180 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-180 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma glucose area under the curve
Secondary outcome measures
Plasma insulin area under the curve
Other outcome measures
Hypoglycemia symptom score

Side effects data

From 2021 Phase 4 trial • 329 Patients • NCT03101930
25%
Study day procedure adverse event
4%
Nausea
4%
Diverticulitis
4%
Bradycardia
4%
Lightheaded
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hypocaloric Diet
Liraglutide
Sitagliptin

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Exendin(9-39)Experimental Treatment1 Intervention
IV infusion of Exendin (9-39).
Group II: PlaceboPlacebo Group1 Intervention
IV infusion of normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avexitide
Not yet FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Tracey McLaughlinLead Sponsor
2 Previous Clinical Trials
28 Total Patients Enrolled
Colleen Craig, M.D.Study DirectorStanford University

Media Library

Exendin (9-39) (GLP-1 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02550145 — Phase 1
Low Blood Sugar Research Study Groups: Exendin(9-39), Placebo
Low Blood Sugar Clinical Trial 2023: Exendin (9-39) Highlights & Side Effects. Trial Name: NCT02550145 — Phase 1
Exendin (9-39) (GLP-1 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02550145 — Phase 1

Frequently Asked Questions

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

Has Exendin (9-39) been sanctioned for use by the FDA?

"With only a few studies to support its safety and efficacy, Exendin (9-39) was assigned an initial score of 1."

Answered by AI

What criteria must I meet in order to qualify for participation in this research?

"This trial is recruiting 30 individuals who have been diagnosed with severe symptomatic hypoglycemia following bariatric surgery and are aged between 18-65. Additional requisites include a BMI ranging from 25-40 for all male/female participants."

Answered by AI

Could you please detail the prior research conducted with Exendin (9-39)?

"Currently, there is a single clinical trial for Exendin (9-39). The majority of the participants are based in Stanford, California yet there exists an additional location hosting this study. Unfortunately, no Phase 3 trials have been initiated as of now."

Answered by AI

Is enrollment for this clinical trial still available?

"This particular trial is no longer looking for participants. It was initially posted on February 1st 2014 and last edited July 1st 2016. For people searching for related studies, there are 86 clinical trials actively recruiting patients with hypoglycemia and one research project targeting Exendin (9-39)."

Answered by AI

Is the trial open to individuals below seventy years of age?

"The cutoff date for inclusion in this trial is within the 18-65 age range. However, if you are younger than 18 or older than 65 there are still 13 and 60 studies respectively that you may be eligible to participate in."

Answered by AI

What is the enrollment rate of this clinical investigation?

"Currently, this medical trial is not accepting new patients. It was initially posted on February 1st 2014 and most recently edited July 1st 2016. If you are searching for other studies, there are 86 active trials recruiting individuals with hypoglycemia and one study offering Exendin (9-39)."

Answered by AI
~3 spots leftby Mar 2025