Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Post-Bariatric Hypoglycemia

In brief

The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods * 19 weeks for the Core Phase. It is composed of: * a Screening period: a maximum of 3 weeks * a Run-in period (no treatment): 4 weeks * a Blinded Treatment Phase: 12 weeks * 36 weeks Extension Phase = an open-label Treatment period * 4 weeks for the safety follow-up period (without any treatment).

Key facts

Study ID

NCT05928390

Run by

RECORDATI GROUP

People needed

93

Starts

2024-01-04

Expected to finish

2026-04-01

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or- non-pregnant female patients ≥ 18 years of age
• Patients able to provide and have provided signed written informed consent prior to study participation.
• Patients capable of self-injecting subcutaneously. Specific training to self-inject the study drug will be provided.
• Post-bariatric surgery more than 6 months prior to screening
• Patients with a medically documented diagnosis of PBH and documented glucose measurement (less than 70 mg/dl or 3.9 mmol/L) with symptoms of hypoglycaemia, and resolution following administration of rescue carbohydrates
• Patients must have ≥ 4 post-prandial hypoglycaemia during the 28-day run-in period (in average ≥1 event over a 7-day week) defined as:
• Blood glucose less than 54 mg/dL (3.0 mmol/L) as measured by SMBG (level 2) or
• Level 3 hypoglycaemic event
• (The previous inclusion criterion number 7 has been deleted).
• Patients in whom dietary control has not sufficiently controlled symptoms of PBH.
• Karnofsky Performance Status ≥ 60 (i.e., requires occasional assistance, but is able to care for most of their personal needs)
• Patients who received other therapies for PBH (such as acarbose, gama guar, pectin, diazoxide) must have stopped all treatments and such treatments are prohibited for a period of at least 2 weeks or 5 half-life times prior to entering the screening period.
• GLP-1 antagonists and GLP-1 agonists for patients who have been treated with in the past for the indication of PBH, are prohibited for a period of at least 4 weeks before the start of the screening period.
• SGLT2 inhibitors (glifozins) for patients who have been treated with in the past for the indication of PBH, are prohibited for a period of at least 4 weeks before the start of the screening period.
• Patients who have been treated with somatostatin receptor analogues in the past, must have an appropriate interval between the last administration of somatostatin receptor analogues treatment and the start of the run-in period as follows:
• Octreotide s.c. for ≥ 72 hours
• Octreotide LAR for ≥ 56 days (8 weeks)
• Lanreotide Autogel for ≥ 98 days (14 weeks)
• Lanreotide SR ≥ 28 days (4 weeks)
• Pasireotide s.c. for ≥ 72 hours (3 days)
• Pasireotide LAR for ≥ 84 days (12 weeks)

You may not qualify if…

• Bariatric patients who have lap band.
• Patients with a current diagnosis of uncontrolled Diabetes Mellitus. However, diabetic patients in remission, as defined below, are eligible:
• With an HbA1c at screening less than 6.5%
• Not taking any medications for hyperglycaemia for at least 3 months prior to screening.
• Their qualifying Level 3 hypoglycaemia events (see above) must have occurred at least 1 month after the discontinuation of the glucose lowering agent(s).
• Patients with hypocortisolism, as defined by serum cortisol levels minor of LLN with presence of clinical signs and symptoms of adrenal insufficiency (e.g., weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyponatremia, or hypoglycaemia) as judged by the Investigators
• (The previous exclusion criterion number 4 has been deleted).
• (The previous exclusion criterion number 5 has been deleted).
• Patients who have a known hypersensitivity to somatostatin receptor analogues.
• Patients currently using medications that may interfere with glucose metabolism within 5 half-lives of drug.
• Patients with history of or current insulinoma.
• Patients who have any severe and/or uncontrolled medical condition or other conditions that could affect their participation in the study such as:
• Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive HIV test result (ELISA and Western blot). An HIV test will not be required; however, previous medical history will be reviewed.
• Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment.
• Life-threatening autoimmune and ischemic disorders.
• Inadequate end organ function as defined by:
• Inadequate bone marrow function:
• WBC less than 3.0 x 109/L
• Absolute Neutrophil Count (ANC) less than 1.5 x 109/L
• Platelets less than100 x 109/L
• Hgb less than 11 g/dL
• INR ≥ 1.5
• eGFR less than 30 mL/min/1.73m2
• Alkaline phosphatase more than 2.5 x ULN
• Serum total bilirubin more than1.5 x ULN

Where it is running

• Stanford University School of Medicine, Endocrinology, 800 Welch Road, — Palo Alto, California, United States
• Northwestern University - Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• NOLA Care — Metairie, Louisiana, United States
• Velocity Clinical Research - Annapolis — Annapolis, Maryland, United States
• Joslin Diabetes CenterJoslin Diabetes Center, One Joslin Place — Boston, Massachusetts, United States
• Mayo Clinic - Rochester, 200 First Street, SW, 55905 — Rochester, Minnesota, United States
• Montefiore Medical Center, 111 E 210th Street, — The Bronx, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, — San Antonio, Texas, United States
• University of Wisconsin Health W. E. Clinic END, 451 Junction Rd, — Madison, Wisconsin, United States
• Universitaire Ziekenhuizen Leuven, Department of Gastroenterology and Hepatology,Herestraat 49 — Leuven, Belgium
• AP-HP Hopital Europeen Georges Pompidou, 20, rue Leblanc, — Paris, France
• HCL Centre Hospitalier Lyon Sud — Pierre-Bénite, France
• Hopital Rangueil, Attachée de Recherche Clinique, Centre Investigation Clinique, CHU, Cedex 9, France — Toulouse, France
• IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola — Bologna, Italy
• Azienda Ospedale - Università Padova, Clinica Medica 3, Via Giustiniani, 2, — Padova, Italy
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone — Palermo, Italy
• Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore, L.go Gemelli 8 — Rome, Italy
• Hospital Universitario Vall d'Hebron, Passeig Vall d´Hebron 119-129, Spain — Barcelona, Spain
• Hospital Clinic Barcelona, Lipid Clinic End, Nutr. Service Hospital Clinic, C. Villarroel, 170, — Barcelona, Spain
• Hospital Germans Trias i Pujol — Barcelona, Spain
• Hospital Universitario Reina Sofia — Córdoba, Spain
• Hospital Universitari de Girona Dr. Josep Trueta — Girona, Spain
• Hospital Clinico San Carlos, C/ Prof Martin Lagos s/n, Spain — Madrid, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain

Full record on ClinicalTrials.gov

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