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

NCT05928390 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: SOM230-RECAG-CL-0576
• Study Type: interventional
• Target: 93
• Locations: 6 countries
• Sites: 29

Brief Summary

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).

Conditions

Post-Bariatric Hypoglycemia

Keywords

PBH; Post Bariatric

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficacy of pasireotide s.c. on blood glucose concentration during an MMTT in patients with PBH after 12 weeks of treatment.

  Change in the blood glucose levels, as measured by the peak to nadir glucose AUC during MMTT

  at baseline and at 12 weeks

Secondary Outcomes (15)

• KEY SECONDARY_CORE PHASE: Evaluation the change of blood glucose nadir and peak during a mixed meal tolerance test (MMTT) at baseline

  at baseline and at 12 weeks

• CORE PHASE: Evaluation of the change of blood glucose nadir and peak during a mixed meal tolerance test (MMTT) at baseline and the MMTT

  baseline and 12 weeks

• CORE PHASE: Evaluation of the efficacy of pasireotide s.c. on the change from baseline of level 2 hypoglycaemic events during a MMTT in patients with PBH

  at 12 weeks

• CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (SF-36 score)

  at 12 weeks

• CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Dumping Score Questionnaire)

  at 12 weeks

Study Arms (4)

Pasireotide s.c. 50 mcg

EXPERIMENTAL

Pasireotide 50 mcg s.c. tid

Drug: Pasireotide Diaspartate

Pasireotide 100 mcg

EXPERIMENTAL

Pasireotide 100 mcg s.c. tid

Drug: Pasireotide Diaspartate

Pasireotide 200 mcg

EXPERIMENTAL

Pasireotide 200 mcg s.c. tid

Drug: Pasireotide Diaspartate

Placebo

PLACEBO COMPARATOR

Placebo s.c. tid

Drug: Pasireotide Diaspartate

Interventions

Pasireotide Diaspartate DRUG

Injectable ampoules

Also known as: Pasireotide

Pasireotide 100 mcg; Pasireotide 200 mcg; Pasireotide s.c. 50 mcg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

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
• 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:

Sponsors & Collaborators

• RECORDATI GROUP: lead

Study Sites (29)

Stanford University School of Medicine, Endocrinology, 800 Welch Road,

Palo Alto, California, 94305, United States

Location

Northwestern University - Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60628, United States

Location

NOLA Care

Metairie, Louisiana, 70006, United States

Location

Velocity Clinical Research - Annapolis

Annapolis, Maryland, 21401, United States

Location

Joslin Diabetes CenterJoslin Diabetes Center, One Joslin Place

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic - Rochester, 200 First Street, SW, 55905

Rochester, Minnesota, 55905, United States

Location

Montefiore Medical Center, 111 E 210th Street,

The Bronx, New York, 10467, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States

Location

University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr,

San Antonio, Texas, 78229, United States

Location

University of Wisconsin Health W. E. Clinic END, 451 Junction Rd,

Madison, Wisconsin, 53717, United States

Location

Universitaire Ziekenhuizen Leuven, Department of Gastroenterology and Hepatology,Herestraat 49

Leuven, 3000, Belgium

Location

AP-HP Hopital Europeen Georges Pompidou, 20, rue Leblanc,

Paris, 75015, France

Location

HCL Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital Rangueil, Attachée de Recherche Clinique, Centre Investigation Clinique, CHU, Cedex 9, France

Toulouse, 31059, France

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola

Bologna, 40138, Italy

Location

Azienda Ospedale - Università Padova, Clinica Medica 3, Via Giustiniani, 2,

Padua, 35128, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore, L.go Gemelli 8

Rome, Italy

Location

Hospital Universitario Vall d'Hebron, Passeig Vall d´Hebron 119-129, Spain

Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona, Lipid Clinic End, Nutr. Service Hospital Clinic, C. Villarroel, 170,

Barcelona, 08036, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta

Girona, Spain

Location

Hospital Clinico San Carlos, C/ Prof Martin Lagos s/n, Spain

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

Location

King's College Hospital NHS Foundation Trust, Denmark Hill, SE5 9RS

London, EC1A 1AA, United Kingdom

Location

Hammersmith Hospital

London, W12 OHS, United Kingdom

Location

Guy's Hospital

London, United Kingdom

Location

MeSH Terms

Interventions

pasireotide

Study Officials

• Arnd H MUELLER, MD

  Recordati AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: January 4, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

IT (4); ES (7); FR (3); BE (1); US (10); GB (4)