A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Avexitide in Participants With Post-Bariatric Hypoglycemia

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB). The study will assess avexitide compared to placebo for safety and efficacy, measured by reduction of hypoglycemic events. The study includes a Screening period with a Run-in period (of up to 6- and 3-weeks, respectively); a randomized, double-blind, placebo-controlled study treatment period of 16 weeks; and a two-part open-label extension (OLE) period with a duration of approximately 32 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Able to provide written informed consent and understand the purpose and risks of the study

• Willing and able to adhere to study requirements, including the use of the study-provided CGM device, SMBG device, and eDiary device as well as the other study evaluations and procedures.

• Is male or female, at least 18 years of age (inclusive) at the time of consent.

• Body mass index (BMI) of up to 40 kg/m2 and has stable body weight-i.e., not varying by \>5% for at least 2 months prior to Screening

• Has undergone documented RYGB performed ≥12 months prior to Screening.

• Has clinical diagnosis of PBH-defined as history of recurrent hypoglycemia with onset after surgery and having ruled out other causes of hypoglycemia as per Investigator judgment.

• Has recurrent hypoglycemia, as demonstrated by experiencing at least 3 discrete hypoglycemic episodes during the 3-week study Run-in period.

• Must agree to consistently follow the dietary management guidance and to maintain consistent exercise and/or physical activity level throughout the Screening period (including the Run-in period), the Double-Blind study treatment period, and Part A of the OLE period.

• If female, must meet all of the following:

‣ Is not breastfeeding or lactating;

⁃ If of childbearing potential, has negative serum pregnancy test result at Screening and on Day 1 ahead of dosing

⁃ If of childbearing potential, must also agree to use a highly effective method of birth control-and agree not to participate in egg (ova) donation or storage, throughout the duration of study participation and for at least 1 month after the last dose of study drug.

• If male and engaging in heterosexual intercourse with a female partner of childbearing potential, must utilize a highly effective method of contraception, and agree not to donate sperm, from the time of providing written informed consent until at least 3 months after the last dose of study drug.

Locations
United States
California
Stanford Health Care - Endocrinology Clinic
RECRUITING
Stanford
Colorado
University of Colorado Health Anschutz Medical Campus
RECRUITING
Aurora
Florida
East Coast Institute for Research
RECRUITING
Jacksonville
Hanson Diabetes Center
RECRUITING
Port Charlotte
Georgia
Georgia Clincal Research
RECRUITING
Lawrenceville
Kansas
Cotton-O'Neil Diabetes and Endocrinology Center
RECRUITING
Topeka
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Joslin Diabetes Center
RECRUITING
Boston
North Carolina
Duke Center for Metabolic and Weight Loss Surgery
RECRUITING
Durham
Lucas Research - Morehead City
RECRUITING
Morehead City
New York
NYC Health + Hospitals/Queens - BRANY
RECRUITING
New Hyde Park
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
Penn Medicine University City
RECRUITING
Philadelphia
Tennessee
Vanderbilt Weight Loss Center
RECRUITING
Nashville
Texas
Endocrine and Psychiatry Center
RECRUITING
Houston
Southern Endocrinology & Diabetes Associates
RECRUITING
Mesquite
Diabetes and Gandular Disease Clinic
RECRUITING
San Antonio
UT Health San Antonio
RECRUITING
San Antonio
Consano Clinical Research
RECRUITING
Shavano Park
Texas Valley Clinical Research, LLC
RECRUITING
Weslaco
Wisconsin
UWHealth - Junction Rd Medical Center Endocrinology Clinic
RECRUITING
Madison
Contact Information
Primary
Amylyx Clinical Trials Team
clinicaltrials@amylyx.com
1-857-575-7007
Backup
Amylyx Medical Director
clinicaltrials@amylyx.com
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2026-10
Participants
Target number of participants: 75
Treatments
Experimental: AVEXITIDE
Avexitide (90 mg via subcutaneous \[SC\] injection) will be taken once per day, in the morning at least 60 minutes before the morning meal, through the duration of the treatment and OLE periods.
Placebo_comparator: PLACEBO
Placebo will be taken once per day, via subcutaneous \[SC\] injection, in the morning at least 60 minutes before the morning meal, through the duration of the treatment period.~Participants receiving Placebo in the double-blind treatment period will transition to Avexitide 90 mg (via subcutaneous \[SC\] injection) in the open-label extension (OLE) period.
Related Therapeutic Areas
Sponsors
Leads: Amylyx Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov