Post Bariatric HypoglycemiaPhase 3LUCIDITYNCT06747468
Avexitide for Treatment of Post-Bariatric Hypoglycemia
A Phase 3 study testing Avexitide in people with Post Bariatric Hypoglycemia, run by Amylyx Pharmaceuticals Inc. at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Bariatric Hypoglycemia
- What is being tested?
- Avexitide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 21 sitesUnited States
- Study dates
- 29 Apr 2025to Feb 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Has received avexitide (exendin 9-39) at any time prior to Screening Visit 1.
- Has received another investigational drug, for any indication, within 5 half-lives of that drug prior to Screening Visit 1.
- Has participated in another interventional clinical study within 30 days prior to Screening Visit 1.
- Presence of gastrostomy tube (G-tube).
- Any known or suspected allergy to one of the investigational medicinal products (avexitide or placebo) or any related product (e.g., exenatide).
- History or presence of insulinoma or other cause of endogenous hyperinsulinism other than PBH.
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- Active psychiatric disease or active eating disorder (e.g., uncontrolled major depressive disorder, schizophrenia, bipolar disorder, or other severe mood, anxiety, or eating disorder). Note: prospective participants with stable conditions, per Investigator judgement, may be considered, provided they are not on an excluded medication.
- History of major surgery within 6 months prior to Screening.
- History of upper GI surgery, other than RYGB. Note that history of vertical sleeve gastrectomy (VSG) with subsequent RYGB conversion may be considered on a case-by-case basis upon discussion with the Medical Monitor.
- Current or prior use of agent(s) that may alter glucose metabolism, or promote weight loss, within 5 medication half-lives of Screening Visit 1. Such agents include, but are not limited to, the following: acarbose; calcium channel blockers; diazoxide; dipeptidyl-peptidase-4 (DPP-4) inhibitors; GLP-1 agonists; glucocorticoids; glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 dual agonists; insulin; lithium; meglitinides; metformin; pentamide; sodium-glucose-linked transporter (SGLT)-1 inhibitors; SGLT-2 inhibitors; somatostatin analogs; sulfonylureas; and thiazolidinediones (TZDs).
- Use of drugs that interfere with the Dexcom G7 sensor within 5 half-lives of Screening Visit 1. Such drugs include acetaminophen administered at a dosage greater than 1000 mg every 6 hours, and hydroxyurea.
- Investigator-assessed evidence of alcohol or drug abuse within 12 months prior to Screening. Unwillingness to restrict alcohol use to no more than 1 drink per day is also exclusionary.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Colorado Health Anschutz Medical Campus
Aurora, Colorado, 80045-2541
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Joslin Diabetes Center
Boston, Massachusetts, 02215-5306
Cleveland Clinic
Cleveland, Ohio, 44195-0001
Duke Center for Metabolic and Weight Loss Surgery
Durham, North Carolina, 27704-2726
Endocrine and Psychiatry Center
Houston, Texas, 77095-2856
East Coast Institute for Research
Jacksonville, Florida, 32216
Georgia Clincal Research
Lawrenceville, Georgia, 30044
UWHealth - Junction Rd Medical Center Endocrinology Clinic
Madison, Wisconsin, 53717-2656
Southern Endocrinology & Diabetes Associates
Mesquite, Texas, 75149
Centricity Research Morehead City Multispecialty
Morehead City, North Carolina, 28557-3126
Vanderbilt Weight Loss Center
Nashville, Tennessee, 37212-3609
NYC Health + Hospitals/Queens - BRANY
New Hyde Park, New York, 11042-1214
Penn Medicine University City
Philadelphia, Pennsylvania, 19104
Hanson Diabetes Center
Port Charlotte, Florida, 33952-6722
UT Health San Antonio
San Antonio, Texas, 78229-3931
Diabetes and Gandular Disease Clinic
San Antonio, Texas, 78229-4801
Consano Clinical Research
Shavano Park, Texas, 78231-1281
Stanford Health Care - Endocrinology Clinic
Stanford, California, 94304
Cotton-O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606-2806
Texas Valley Clinical Research, LLC
Weslaco, Texas, 78596-7288
About this study
Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Avexitide in Participants With Post-Bariatric Hypoglycemia
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.
Read the detailed description
AVX-001 (LUCIDITY) is a Phase 3 multicenter study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB).
Eligible participants must have a confirmed diagnosis of PBH related to RYGB, must be a minimum of 1-year post-surgery, and must have experienced at least 3 discrete hypoglycemic events during the 3-week study Run-in period while adhering to consistent dietary management.
The study includes a Screening period of up to 6 weeks in duration, inclusive of a 3-week Run-in period; a randomized, double-blind, placebo-controlled study treatment period of 16 weeks in duration; and a two-part open-label extension (OLE) period with a duration of 32 weeks.
The Double-Blind period is designed to evaluate the efficacy and safety of 90 mg per day of avexitide (given by subcutaneous injection) compared to placebo in participants with PBH after Roux-en-Y gastric bypass (RYGB), who are not adequately controlled on dietary management for reduction of hypoglycemic events.
The subsequent 32-week Open Label Extension (OLE) period is intended to further evaluate the safety and efficacy of avexitide (90 mg per day, given by subcutaneous injection) in participants who have completed the Double-Blind period. The OLE period consists of an 8-week initial Part A and a subsequent 24-week Part B.
Participants will use a continuous glucose monitor (CGM) in blinded mode, a self-monitoring of blood glucose (SMBG) device (glucose meter), and an electronic diary (eDiary) on a smartphone to record hypoglycemic events and study drug administration during the screening period, 16-week double-blind period, and 8-week OLE Part A. While the CGM is in blinded mode, participants will not see their specific blood glucose values on their CGM, but they will receive an alert when their blood glucose is low; they may check their blood glucose via the SMBG glucose meter device at any time. During the 24-week OLE Part B, participants will use a CGM in unblinded mode (blood glucose values are visible to the participant) and the SMBG and eDiary devices will not be assessed.
- Conditions
- Post Bariatric Hypoglycemia
- Being tested
- Avexitide, Placebo
- Keywords
- avexitide, post bariatric hypoglycemia, PBH, hypoglycemia, hypoglycemia post bariatric surgery, Roux-en-Y gastric bypass (RYGB), RYGB, AVX, LUCIDITY, exendin 9-39, exendin, exendin 939, Roux-en-Y, gastric bypass, low blood sugar, Roux-en-Y gastric bypass
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvexitideDrug
Also called exendin 9-39
Avexitide (also known as exendin 9-39), a first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist, is a 31-amino acid peptide with a free amino group at the N-terminus and an amidated C-terminus. By binding to the GLP-1 receptor, avexitide inhibits GLP-1 receptor signaling, thereby reducing GLP-1 receptor-mediated insulin secretion
PlaceboOther
Matching placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| AVEXITIDE | Experimental | 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. Receives: Drug: Avexitide |
| PLACEBO | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of Level 2 and Level 3 hypoglycemic events
Composite rate of Level 2 hypoglycemia (as measured by self-monitoring of blood glucose [SMBG]) and Level 3 hypoglycemia (per American Diabetes Association [ADA], European Association for the Study of Diabetes [EASD]; adjudicated by independent Event Adjudication Committee [EAC]), assessed during the Double-Blind study treatment period
Measured: During the double-blind treatment period (approximately 16 weeks)
Safety and Tolerability of avexitide
Incidence of adverse events (AEs)-e.g., incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), AEs of special interest (AESIs), and TEAEs leading to discontinuation-and other safety assessments (e.g., clinical laboratory results and vital sign measurements), assessed during the Double-Blind study treatment period
Measured: During the double-blind treatment period (approximately 16 weeks)
Incidence of anti-drug antibodies (ADAb)
Incidence of ADAb, assessed during the Double-Blind study treatment period
Measured: During the double-blind treatment period (approximately 16 weeks)
Secondary outcomes (1)
Further evaluate the efficacy of avexitide compared to placebo for reduction of hypoglycemia
Rates of the following, assessed during the Double-Blind study treatment period:
- Level 2 hypoglycemia as measured by SMBG
- Level 3 hypoglycemia, adjudicated by EAC
- Level 2 hypoglycemia as measured by CGM
Measured: During the double-blind treatment period (approximately 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start29 Apr 2025
- Primary completion8 Jul 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Bariatric HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Upon entering the Double-Blind period, approximately 75 participants will be randomized and assigned in a 3:2 ratio to either the avexitide treatment group or the placebo group, respectively.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amylyx Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amylyx Medical Director, Study director, Amylyx Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747468
- Sponsor's protocol ID
- AVX-001
- Acronym
- LUCIDITY
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Proposals for access to IPD by qualified investigators will be reviewed by an independent review committee. Only the de-identified data elements needed to achieve the specific scientific aims of a proposal as outlined in a pre-specified analysis plan will be provided. Study documents such as protocol, SAP, ICF, and CSR, may be provided, if requested and if needed, to conduct the specified analyses.