Reactive Hypoglycemia > Pasireotide

Pasireotide for Low Blood Sugar (PASIPHY Trial)

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: RECORDATI GROUP

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?

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).

How is the drug pasireotide unique for treating low blood sugar?

Pasireotide is unique because it is a multireceptor-targeted somatostatin analog that binds to multiple somatostatin receptor subtypes, which is broader than other similar drugs. This allows it to potentially offer symptom control in conditions where other treatments may not be effective.

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Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications for post-bariatric hypoglycemia, such as acarbose, GLP-1 antagonists, and SGLT2 inhibitors, at least 2 to 4 weeks before the screening period. If you are on anticoagulation therapy, a washout period of at least 10 days is needed. Other medications that interfere with glucose metabolism must also be stopped within 5 half-lives of the drug.

Eligibility Criteria

This trial is for adults over 18 who've had bariatric surgery at least 6 months ago and suffer from low blood sugar after meals but not when fasting. They must be able to self-inject medication after training, have a history of specific symptoms related to low blood sugar, and provide written consent.

Inclusion Criteria

I've waited the required time after my last somatostatin treatment to start a new trial.

I have been diagnosed with low blood sugar after weight-loss surgery.

I can care for myself but may not be able to do active work.

Exclusion Criteria

I have been treated with pasireotide before.

I have a blood clotting disorder or I am on constant blood thinners.

I have a lap band from bariatric surgery.

I have an underactive thyroid and am not on treatment.

I have not been seriously ill in the last two weeks.

I am not on medications that affect blood sugar levels.

I have or had an insulin-producing tumor in my pancreas.

I have gallstones or pancreatitis that causes symptoms.

My heart rate and ECG results meet the study's requirements.

I had major surgery within the last month.

I am not pregnant, planning to become pregnant, or breastfeeding during the study.

I am not willing to use effective birth control methods.

Participant Groups

The study tests Pasireotide Diaspartate in patients with post-bariatric hypoglycemia over a maximum of 59 weeks. It includes a no-treatment run-in period, a blinded treatment phase for 12 weeks, followed by an open-label extension phase for 36 weeks, and ends with a safety follow-up without treatment.

Group I: Pasireotide s.c. 50 mcg Experimental Treatment 1 Intervention

Pasireotide 50 mcg s.c. tid

Group II: Pasireotide 200 mcg Experimental Treatment 1 Intervention

Pasireotide 200 mcg s.c. tid

Group III: Pasireotide 100 mcg Experimental Treatment 1 Intervention

Pasireotide 100 mcg s.c. tid

Group IV: Placebo Placebo Group 1 Intervention

Placebo s.c. tid

Pasireotide is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Signifor for:

• Cushing's disease

🇪🇺 Approved in European Union as Signifor for:

• Cushing's disease

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Stanford University School of Medicine, Endocrinology, 800 Welch Road, Palo Alto,, CA

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

Vanderbilt University Medical Center Nashville, TN

Joslin Diabetes CenterJoslin Diabetes Center, One Joslin Place Boston, MA

More Trial Locations

Who is running the clinical trial?

RECORDATI GROUP Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Pasireotide (SOM230) shows efficacy and tolerability in the treatment of patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR: results from a phase II study. [2014] Pasireotide (SOM230) is a novel multireceptor-targeted somatostatin (sst) analog with high binding affinity for sst receptor subtype 1, 2, 3 (sst(1,2,3)) and sst(5). Because of this binding profile, pasireotide may offer symptom control in patients with neuroendocrine tumors (NETs) and carcinoid syndrome no longer responsive to octreotide LAR. This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR. Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved. Forty-four patients were evaluated for efficacy and 45 for tolerability. Pasireotide 600-900 μg s.c. bid effectively controlled the symptoms of diarrhea and flushing in 27% of patients. Evaluation of tumor response in 23 patients showed 13 with stable disease and ten with progressive disease at study end. The most common drug-related adverse events were nausea (27%), abdominal pain (20%), weight loss (20%), and hyperglycemia (16%) and most were of mild or moderate severity. Pasireotide 600-900 μg s.c. bid was effective and generally well tolerated in controlling the symptoms of carcinoid syndrome in 27% of patients with advanced NET refractory or resistant to octreotide LAR therapy.

2. Germany pubmed.ncbi.nlm.nih.gov

Assessment of the absorption, metabolism and excretion of [¹⁴C]pasireotide in healthy volunteers using accelerator mass spectrometry. [2014] Pasireotide (SOM230) is a multireceptor-targeted somatostatin analog designed to have a broader somatostatin receptor binding profile than other currently available somatostatin analogs. The purpose of this study was to evaluate the absorption, metabolism and excretion of pasireotide in healthy male subjects (N = 4) following a single, subcutaneous (sc), 600 μg dose of [¹⁴C]pasireotide.

3. United States pubmed.ncbi.nlm.nih.gov

Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers. [2022] Pasireotide (SOM230) is a somatostatin analog with affinity for somatostatin receptor subtypes sst₁₋₃ and sst₅. Clinical trials have demonstrated the efficacy of pasireotide in treating Cushing's disease and acromegaly but have also shown adverse effects on glucose metabolism.

4. Germany pubmed.ncbi.nlm.nih.gov

Safety, tolerability, pharmacokinetics, and pharmacodynamics of a long-acting release (LAR) formulation of pasireotide (SOM230) in patients with gastroenteropancreatic neuroendocrine tumors: results from a randomized, multicenter, open-label, phase I study. [2022] Pasireotide (SOM230), a novel multireceptor ligand somatostatin analog (SSA), binds with high affinity to four of the five somatostatin receptor subtypes (sst1-3, 5). This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics profiles of pasireotide long-acting release (LAR) formulation in patients with advanced gastroenteropancreatic neuroendocrine tumor (GEP NET) refractory to other SSAs.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Pasireotide - Mechanism of Action and Clinical Applications. [2018] Pasireotide (SOM230) is a multi-receptor ligand somatostatin analogue (SSA) developed as the successor of the first-generation SSAs. Currently, pasireotide is recommended for the treatment of patients with Cushing's disease in whom surgery was unsuccessful, and patients with acromegaly who either remain uncontrolled after surgical therapy or in whom tumor resection is not possible.