Clinical Trials

Inclusion Criteria:

1. Male or- non-pregnant female patients ≥ 18 years of age

2. Patients able to provide and have provided signed written informed consent prior to
study participation.

3. Patients capable of self-injecting subcutaneously. Specific training to self-inject
the study drug will be provided.

4. Post-bariatric surgery more than 6 months prior to screening

5. Patient with a documented diagnosis of PBH defined as having:

- postprandial neuroglycopenia occurring >1 hour after meals

- no hypoglycaemia in fasting conditions

- documented history of Whipple's triad

- documented history of hypoglycaemia based on

- glucose value <50mg/dL or 2.8 mmol/L on a sporadic or scheduled blood analysis -
OR -

- glucose value <60 mg/dL or 3.3 mmol/L at 90, 120, 150 or 180 min during an OGTT
(oral glucose tolerance test) - OR-

- glucose value <54 mg/dL at 60, 90, 120 or 180 min during a 3-hour MMTT (mixed
meal tolerance test)

6. Patients must have at least one glucose level < 54 mg/dL at 30, 90, 120, 150 or 180
min during the 3-hour MMTT at screening

7. Historical evidence of previous level 3 hypoglycaemia events at any time

8. Patients who have failed diet recommended by the treating physician for the PBH

9. Karnofsky Performance Status ≥ 60 (i.e., requires occasional assistance, but is able
to care for most of their personal needs)

10. Patients who received other therapies for PBH (such as acarbose, gama guar, pectin,
diazoxide) must have stopped all treatments and allow a wash out period of at least 2
weeks prior to entering the run-in period.

11. Patients who have been treated with GLP-1 antagonists in the past must have a wash-out
period of at least 4 weeks before the start of the run-in period

12. Patients who have been treated with SGLT2 inhibitors (glifozins) in the past must have
a wash-out period of at least 4 weeks before the start of the run-in period

13. 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)

Exclusion Criteria:

1. Bariatric patients who have lap band.

2. Patients with a current diagnosis of uncontrolled Diabetes Mellitus. However, diabetic
patients in remission, as defined below, are eligible:

- With an HbA1c at screening <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).

3. Patients previously treated with pasireotide at any time

4. Patients who have a known hypersensitivity to somatostatin receptor analogues.

5. Patients currently using medications that may interfere with glucose metabolism within
5 half-lives of drug.

6. Patients with history of or current insulinoma

7. Patients who have any severe and/or uncontrolled medical condition or other conditions
that could affect their participation in the study (defined in the core text of the
protocol)

8. Patients with symptomatic cholelithiasis and/ or acute or chronic pancreatitis.

9. Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits).

10. 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).

11. Patients who are hypothyroid and not on adequate replacement therapy.

12. Patients who have undergone major surgery/surgical therapy for any cause within 1
month. Patients should have recovered from the surgery and be in good clinical
condition before entering the study.

13. Bradycardia and QT-related exclusion criteria (in the core text of the protocol)

14. Participation in any clinical investigation within 4 weeks prior to dosing or longer
if required by local regulation. (Use of an investigational drug within 1 month prior
to dosing).

15. Significant acute illness within the two weeks prior to dosing/randomization.

16. 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.

17. Women of childbearing potential (WOCBP) who are unwilling of using highly effective
contraception methods (definition in core protocol)

18. Potentially unreliable or vulnerable patients (e.g., person kept in detention) and
those judged by the investigator to be unsuitable for the study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/23/23. Questions regarding updates should be directed to the study team contact.