Take the next step to see if you may qualify for the
LUCIDITY Post-Bariatric Hypoglycemia (PBH) research study.

Don’t delay — space is limited!

Take the next step to see if you may qualify for the LUCIDITY Post-Bariatric Hypoglycemia (PBH) research study.

Are You Experiencing Low Blood Sugar Events After Roux-en-Y Gastric Bypass (RYGB) surgery?

A Study for People Living with Post-Bariatric Hypoglycemia is Now Enrolling in the
United States

Or Call: 888-261-4725

Learn more below

Are You Experiencing Low Blood
Sugar Events After Roux-en-Y
Gastric Bypass (RYGB) surgery?

A Study for People Living with
Post-Bariatric Hypoglycemia is
Now Enrolling in the United States

Or Call: 888-261-4725

Learn more below

Local clinical trial now enrolling!

A Study for People Living with Post-Bariatric Hypoglycemia is Now Enrolling in the United States

If you are 18 years of age or older, have had Roux-en-Y gastric bypass (RYGB) surgery at least 12 months ago, are a resident in the United States and have been diagnosed with post-bariatric hypoglycemia (PBH), you may qualify for a local study that’s assessing an investigational drug in people living with PBH. If you qualify and participate, you may receive:

No-cost study-related care
Reimbursement for study-related costs

If you choose to take the next step to see if you may qualify for the LUCIDITY study, you consent to the collection of certain personal information, including health information such as your medical history, for the purpose of pre-screening to determine your potential eligibility for a clinical trial studying an investigational medicine for PBH. You are not obligated to participate in the clinical trial if you are identified as a potential candidate.

Local clinical trial
now enrolling!

A Study for People Living with

Post-Bariatric Hypoglycemia is Now

Enrolling in the United States

No-cost study-related care
Reimbursement for study-related costs

Take the next step to see if you may qualify for the LUCIDITY Study.

Why PBH Research Is Important

What Is PBH?

Post-bariatric hypoglycemia (PBH) is a condition caused by insulin levels that are too high leading to low blood sugar (hypoglycemia) that can sometimes occur in those who have had gastric bypass surgery. Symptoms of PBH typically start 1 year or more after surgery. Symptoms of PBH are caused by low blood sugar and can include sweating, anxiety, blurred vision, confusion, weakness, and passing out. These symptoms usually occur 1 to 3 hours after consuming a snack or meal.

Why/How Does It Happen?

It is not fully understood why some people develop PBH. However, there is evidence that those with PBH have elevated levels of the glucagon-like peptide-1 (GLP-1) hormone after they eat. Normally, GLP-1 is produced in response to a meal and binds to receptors on the pancreas. This signals the pancreas to release insulin, which lowers blood sugar. With PBH, however, abnormally high GLP-1 results in too much insulin being released. This, in turn, causes blood sugar levels to drop too low.

What Is PBH?

At present, there are no approved treatments for PBH, which is why there is an urgent need to develop new treatments. As such, the main goals of the LUCIDITY study are to see whether the investigational drug can help reduce the number of serious hypoglycemic events in people living with PBH after having Roux-en-Y gastric bypass (RYGB) surgery and to assess the safety and tolerability of the investigational drug.

Your personal information will be kept private, and your health will be monitored throughout the study. If you qualify and choose to enroll, you may still leave the study at any time, for any reason.

Please consider enrolling today…

LUCIDITY Study Overview

The phase 3 LUCIDITY study (NCT06747468) will evaluate if the investigational drug, avexitide, is safe and effective as a treatment for adults living with post-bariatric hypoglycemia (PBH).

The LUCIDITY study will last up to 58 weeks or slightly over one year. There will be three main study periods and a safety follow-up:

Screening Period (up to 6 weeks):
Participants will be evaluated if they qualify to enroll in the study.

1 in-person visit, 1 remote OR in-person visit

Screening Period (up to 6 weeks):
Participants will be evaluated if they qualify to enroll in the study.

1 in-person visit, 1 remote OR
in-person visit

Double-Blind Treatment Period (16 weeks):
Participants will be chosen at random to receive either avexitide or placebo. The chances of receiving avexitide are higher than that of receiving placebo: for every three people taking avexitide, two will take placebo.

5 in-person visits, 1 remote visit

5 in-person visits, 1 remote visit

Open-label Extension (OLE) Period (32 weeks):
The OLE will be 32 weeks. Participants completing the double-blind treatment period will be given the option to enroll in the OLE period where all participants receive avexitide.

6 in-person visits, 2 remote visits

6 in-person visits, 2 remote visits

Safety Follow-Up Visit (occurs 4 weeks after the last dose of study drug):
1 in-person visit

Safety Follow-Up Visit (occurs 4 weeks after the last dose of study drug):

1 in-person visit

LUCIDITY Study Overview

A clinical research study has specific eligibility criteria to ensure study goals are met.

You may be eligible for the LUCIDITY study if you:

Are at least 18 years of age.
Have a diagnosis of post-bariatric hypoglycemia (PBH).

Have undergone Roux-en-Y gastric bypass (RYGB) surgery 12 or more months ago.
Have recurrent episodes of low blood sugar despite consistent dietary management.

Visit www.clinicaltrials.gov for the additional LUCIDITY study eligibility criteria.

About the Study Drug

The investigational drug, avexitide, is a GLP-1 receptor antagonist. Avexitide blocks where GLP-1 binds to receptors on the pancreas. Avexitide is considered investigational because it has not been approved by the FDA to treat people living with PBH. The trial will compare the safety and effectiveness of avexitide to placebo. A placebo looks and tastes the same as the investigational drug and is given the same way. However, the placebo does not contain the investigational drug. Both avexitide and placebo are referred to as “study drug.” Study drug will be injected under the skin (“subcutaneously”).

Where will the LUCIDITY study take place?

The LUCIDITY study will be conducted at ~20 sites across the United States. The latest information on sites that are open and enrolling is available at www.clinicaltrials.gov.