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Post-Bariatric HypoglycemiaPhase 2PASIPHYNCT05928390

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

A Phase 2 study testing Pasireotide Diaspartate in people with Post-Bariatric Hypoglycemia, run by RECORDATI GROUP at 29 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. 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?
Pasireotide Diaspartate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
29 sitesin 6 countries
Study dates
4 Jan 2024to 29 Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 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:
Show all 21Show fewer
  • 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)

Who cannot join

  • 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
Show all 60Show fewer
  • (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
  • ALT and AST more than 1.5 x ULN
  • History of liver disease, such as cirrhosis or chronic active hepatitis B andC
  • Presence of Hepatitis B surface antigen (HbsAg) and/ or Presence of Hepatitis C antibody test (anti-HCV). Patients with positive HCV Ab must undergo reflex HCV RNA testing, and patients with HCV RNA positivity will be excluded. Patients with positive HCV Ab and negative HCV RNA are eligible.
  • History of, or current alcohol and/or drug misuse/abuse within the past 12 months. A drug/alcohol test will not be required; however, previous medical history will be reviewed.
  • Patients with symptomatic cholelithiasis and/ or acute or chronic pancreatitis.
  • Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits).
  • Patients on continuous anticoagulation therapy. Patients who were on anticoagulant therapy must complete a washout period of at least 10 days and have confirmed normal coagulation parameters before study inclusion (patients receiving aspirin once a day are allowed to be enrolled).
  • Patients who are hypothyroid and not on adequate replacement therapy.
  • Patients who have undergone major surgery/surgical therapy for any cause within 1 month before screening. Patients should have recovered from the surgery and be in good clinical condition before entering the study.
  • Patients requiring gastrostomy tube feedings.
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study.
  • Clinically significant abnormal laboratory values considered by the Investigator or the medical monitor of the sponsor to be clinically significant or which could have affected the interpretation of the study results.
  • Bradycardia and QT-related exclusion criteria:
  • Patients with long QT syndrome or QTcF more than 450 ms for male and QTcF more than 460 ms for female detected at screening.
  • Patients with uncontrolled or significant cardiac disease, including recent myocardial infarction, unstable angina, congestive heart failure, clinically significant/symptomatic heart rate less than50 bpm, or high-grade AV block, sustained ventricular tachycardia, ventricular fibrillation.
  • History of syncope or family history of idiopathic sudden death.
  • Sustained or clinically significant cardiac arrhythmias.
  • Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson\'s disease), HIV, cirrhosis, uncontrolled hypothyroidism, or cardiac failure.
  • Family history of long QT syndrome.
  • Concomitant medications known to prolong the QT interval.
  • Hypokalaemia (Potassium less than or = 3.5 mEq/L).
  • Hypomagnesemia (Magnesium less than 0.7 mmol/L).
  • Participation in any clinical investigation within 4 weeks prior to screening or longer if required by local regulation. (Use of an investigational drug within 1 month prior to screening).
  • Significant acute illness within the two weeks prior to dosing.
  • Female patients who are pregnant, intending to become pregnant or breastfeed during the study. or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  • Women of childbearing potential (WOCBP) who are unwilling of using highly effective contraception methods.
  • Highly effective contraception methods include:
  • Combined (estrogen and progesterone containing) (oral, intravaginal, transdermal) hormonal contraception associated with inhibition of ovulation.
  • Progesterone-only hormonal (oral, injectable, implantable) contraception associated with inhibition of ovulation.
  • Intrauterine device.
  • Intrauterine hormone-releasing system.
  • Bilateral tubal occlusion.
  • Sexual abstinence defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.
  • Sexually active males unwilling to use a condom during intercourse while taking the drug and for 4 weeks after pasireotide s.c. last dose. A condom is required to be used also by vasectomized men to prevent delivery of the drug via seminal fluid.
  • Potentially unreliable or vulnerable patients (e.g., person kept in detention) and those judged by the Investigator to be unsuitable for the study.

Trial locations and contacts

29 sites in 6 countries.

29 sites in 6 countries

United States10 sites

  • Velocity Clinical Research - Annapolis

    Annapolis, Maryland, 21401

  • Joslin Diabetes CenterJoslin Diabetes Center, One Joslin Place

    Boston, Massachusetts, 02215

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

    Chicago, Illinois, 60628

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

    Madison, Wisconsin, 53717

  • NOLA Care

    Metairie, Louisiana, 70006

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204

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

    Palo Alto, California, 94305

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

    Rochester, Minnesota, 55905

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

    San Antonio, Texas, 78229

  • Montefiore Medical Center, 111 E 210th Street,

    The Bronx, New York, 10467

Other trials in United States

Spain7 sites

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

    Barcelona, 08035

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

    Barcelona, 08036

  • Hospital Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona

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

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

Italy4 sites

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

    Bologna, 40138

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

    Padova, 35128

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo

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

    Rome

Other trials in Italy

United Kingdom4 sites

  • North Bristol NHS Trust

    Bristol, BS10 5NB

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

    London, EC1A 1AA

  • Hammersmith Hospital

    London, W12 OHS

  • Guy's Hospital

    London

Other trials in United Kingdom

France3 sites

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

    Paris, 75015

  • HCL Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

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

    Toulouse, 31059

Other trials in France

Belgium1 site

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

    Leuven, 3000

Other trials in Belgium

About this study

Official title: A Double-blind Randomized Placebo-controlled Dose-finding Phase II Study to Assess the Efficacy and Safety of Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia

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).
Read the detailed description

Subjects with post-bariatric hypoglycemia will be screened for participation in this trial. Eligible patients will complete the rest of the Core phase by entering a run-in period of 4 weeks without any treatment.

At the end of the run-in period, participants will be randomized to receive in a blinded manner either pasireotide 50 µg or pasireotide 100 µg or pasireotide 200 µg or Placebo subcutaneously three times a day (prior to each meal).

Participants will blindly self-administer their treatment for a total of 12 weeks when the primary endpoint will be assessed.

All participants completing the core phase will be offered to enter the extension phase. Participants will openly self-administer pasireotide 50 µg or pasireotide 100 µg or pasireotide 200 µg subcutaneously three times a day for a total of 36 weeks of treatment. There will be no more placebo during this extension phase of treatment.

Dose changes/adjustments will be possible only during the extension phase and the decision to change the dose of pasireotide will be left to the investigator's judgment.

All participants will come for a safety visit after discontinuation or completion of treatment.

Being tested
Pasireotide Diaspartate
Keywords
PBH, Post Bariatric

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pasireotide DiaspartateDrug

    Also called Pasireotide

    Injectable ampoules

Study groups in NCT05928390
Study groupRoleWhat they receive
Pasireotide s.c. 50 mcgExperimentalPasireotide 50 mcg s.c. tid
Receives: Drug: Pasireotide Diaspartate
Pasireotide 100 mcgExperimentalPasireotide 100 mcg s.c. tid
Receives: Drug: Pasireotide Diaspartate
Pasireotide 200 mcgExperimentalPasireotide 200 mcg s.c. tid
Receives: Drug: Pasireotide Diaspartate
PlaceboPlacebo comparatorPlacebo s.c. tid
Receives: Drug: Pasireotide Diaspartate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at baseline and at 12 weeks

Secondary outcomes (15)

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

    Change from baseline in the rate of the composite (and individual components) of clinically significant hypoglycaemic events as measured as the frequency of level 2 hypoglycaemic events (glucose level <54 mg/dL or 3.0 mmol/L) measured by SMBG OR the frequency of level 3 hypoglycaemic (requiring external assistance) events/4-weeks at 12 weeks of treatment with pasireotide vs placebo

    Measured: at baseline and at 12 weeks

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

    Change in the nadir and peak of blood glucose levels,

    Measured: baseline and 12 weeks

  3. 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

    Change from baseline in the proportion of patients with no level 2 hypoglycaemic events (plasma glucose <54 mg/dL or 3.0 mmol/L) at 60, 90, 105, 120, 135, 150, 165 and 180 min during a 3-hour MMTT

    Measured: at 12 weeks

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

    The 36-item Short Form Health Survey (SF-36) is a patient reported outcomes measure that consists of a 36-item self-report inventory. The SF-36 is an accepted metric for benchmarking indications against normative population-based statistics. It assesses health-related limitations in eight dimensions: physical functioning (PF), role limitations due to physical functioning (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). Two summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), can be calculated from the eight-dimension scores (scale scores).

    Measured: at 12 weeks

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

    DSQ is a disease specific patient reported outcome (PRO) scale that was developed according to the FDA and EMEA guidelines. The questionnaire utilizes a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; and 4, very severe) to ask a patient to evaluate the intensity of 10 early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). In addition, the questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion

    Measured: at 12 weeks

  6. CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Patient Global Assessment)

    It will incorporate a patient global assessment question: "Considering all the way that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study?" Patients Global Assessment will be measured utilizing a 7-point scale (from 1= a lot worse to 7= a lot better).

    Measured: at 12 weeks

  7. CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Hypoglycaemia Fear Survey-II) from baseline

    The Hypoglycaemia Fear Survey (HFS) originally was developed to measure behaviours and worries related to fear of hypoglycaemia (FOH) in adults with type 1 diabetes. Both the original HFS (HFS-I) and the revised version (HFS-II) are composed of two subscales, the Behaviour (HFS-B) and Worry (HFS-W).

    Measured: at 12 weeks

  8. CORE PHASE: Evaluation of the safety profile of pasireotide s.c (AEs)

    Incidence of AEs for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid.

    Measured: for 12 weeks

  9. EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period: (AEs)

    Incidence of AEs for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid.

    Measured: for 36 weeks

  10. CORE PHASE: Evaluation of the safety profile of pasireotide s.c (Labs)

    Incidence of laboratory findings for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid. Changes from baseline in laboratory values and vital signs

    Measured: for 12 weeks

  11. EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period: (Labs)

    Incidence of laboratory findings for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid. Changes from baseline in laboratory values and vital signs

    Measured: for 36 weeks

  12. CORE PHASE: Evaluation of the safety profile of pasireotide s.c (ECG)

    Incidence of ECG findings for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid. Changes from baseline in ECG readings,

    Measured: for 12 weeks

  13. EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period: (ECG)

    Incidence of ECG findings for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid. Changes from baseline in ECG readings,

    Measured: for 36 weeks

  14. CORE PHASE: Evaluation of the safety profile of pasireotide s.c (imaging)

    Changes from baseline in gallbladder imaging

    Measured: for 12 weeks

  15. EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period:(imaging)

    Changes from baseline in gallbladder imaging

    Measured: for 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start4 Jan 2024
  3. Primary completion29 Oct 2026 (estimated)
  4. Study completion29 Oct 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05928390
Sponsor's protocol ID
SOM230-RECAG-CL-0576
Acronym
PASIPHY
Status last verified
Sep 2026
First submitted
23 Jun 2023
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pasireotide Diaspartate in people with Post-Bariatric Hypoglycemia, run by RECORDATI GROUP at 29 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 60 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Spain, Italy, United Kingdom, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the efficacy of pasireotide s.c. on blood glucose concentration during an MMTT in patients with PBH after 12 weeks of treatment. (time frame: at baseline and at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05928390.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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