IRB Study Number 25-303
Status Recruiting
Phase Phase 3
Institute Endocrinology and Metabolism Institute
Description
This is a Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Avexitide in Participants with Post-Bariatric Hypoglycemia.
Inclusion Criteria
- Is able to understand the purpose and risks of the study; willing and able to adhere to the scheduled visits, treatment plans, dietary requirements, laboratory tests, and procedures related to the use of the study-provided CGM device (which will be used in blinded mode during the Run-in period, Double-Blind study treatment period, and Part A of the OLE Period, then in unblinded mode during Part B of the OLE period), SMBG device, and eDiary device as well as the other study evaluations and procedures; and able to provide written informed consent.
- Is male or female, at least 18 years of age (inclusive) at the time of providing written informed consent.
- Has 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—as per participant report.
- 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 (refer to Inclusion Criterion #4 above), characterized by Whipple’s triad (symptoms of hypoglycemia, concurrent low plasma glucose levels, and relief of symptoms by carbohydrate ingestion)—having ruled out other causes of hypoglycemia as per Investigator judgment.
- Has recurrent hypoglycemia, as demonstrated by experiencing at least 3 discrete hypoglycemic episodes (as defined in Section 9.2.2.1 ) during the 3-week Run-in period while adhering to consistent dietary management. At least 2 of the qualifying events must have been Level 2 or greater in severity, and at least 1 event must have been adjudicated by independent EAC as Level 3 (per ADA, EASD).
- Must agree to consistently follow the dietary management guidance summarized in Section 8.1.4 throughout the Screening period (including the Run-in period), the Double-Blind study treatment period, and Part A of the OLE period.
- Must agree 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 criteria as applicable to the participant: Is not breastfeeding or lactating; If of childbearing potential (refer to definition in the note below), has negative serum pregnancy test result (human chorionic gonadotropin, beta subunit) at Screening. Serum pregnancy test performed at Screening and urine pregnancy test performed on Day 1 must be confirmed negative prior to initiation of study drug dosing; and if of childbearing potential (refer to definition in the note below), must also agree to use a highly effective method of birth control—defined as a method which results in a low failure rate (i.e., failure rate of less than 1% per year when used consistently and correctly), such as implants, injectables, hormonal contraceptives, intrauterine contraceptive devices, abstinence from heterosexual intercourse, tubal ligation or occlusion, or a vasectomized male partner— and agree not to participate in egg (ova) donation or storage, throughout the duration of study participation and for at least 4 weeks 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. Such methods of contraception may include the following: Surgical sterilization, such as vasectomy, true abstinence, in accordance with the note regarding abstinence in Inclusion Criterion #9 above. use of highly effective birth control (in accordance with Inclusion Criterion #9 above) by a female partner who is of childbearing potential. The female partner is to utilize highly effective birth control throughout the duration of study participation by the male and until least 3 months after the last dose of study drug taken by the male
Exclusion Criteria
General exclusions
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 within 21 days prior to Screening Visit 1 of active infection considered clinically significant in the opinion of the Investigator.
