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Corticosteroid

Pasireotide 200 mcg for Post-Bariatric Hypoglycemia (PASIPHY Trial)

Phase 2
Recruiting
Research Sponsored by RECORDATI GROUP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have been treated with somatostatin receptor analogues must have an appropriate interval between the last administration of treatment and the start of the run-in period as specified
Patients with a documented diagnosis of Post-Bariatric Hypoglycaemia (PBH) as defined in the criteria provided
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

PASIPHY Trial Summary

This trial will last for a maximum of 59 weeks for participants with post-bariatric hypoglycemia. It includes a Core Phase lasting 19 weeks with different stages such as screening,

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the side effects are not detailed here, Pasireotide can typically cause gastrointestinal issues like nausea or diarrhea, increased blood sugar levels, headache, abdominal pain or discomfort among others.

PASIPHY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've waited the required time after my last somatostatin treatment to start a new trial.
Select...
I have been diagnosed with low blood sugar after weight-loss surgery.
Select...
I can care for myself but may not be able to do active work.

PASIPHY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Level 2 hypoglycaemic events (plasma glucose <54 mg/dL) during a 3-hour MMTT (mixed meal tolerance test)

Side effects data

From 2018 Phase 4 trial • 249 Patients • NCT02060383
37%
Hyperglycaemia
34%
Nausea
29%
Diarrhoea
26%
Weight decreased
13%
Cholelithiasis
13%
Vomiting
13%
Diabetes mellitus
13%
Dizziness
13%
Hypoglycaemia
11%
Headache
11%
Fatigue
11%
Abdominal distension
8%
Urinary tract infection
8%
Glycosylated haemoglobin increased
8%
Lipase increased
8%
Decreased appetite
8%
Hypokalaemia
8%
Muscular weakness
8%
Haematuria
8%
Rash
8%
Constipation
8%
Hypertriglyceridaemia
8%
Nasopharyngitis
8%
Alanine aminotransferase increased
5%
Asthenia
5%
Blood glucose increased
5%
Abdominal pain
5%
Respiratory tract infection viral
5%
Hypotension
5%
Abdominal discomfort
5%
Alopecia
5%
Sepsis
5%
Adrenal insufficiency
5%
Blood creatinine increased
5%
Gamma-glutamyltransferase increased
5%
Dysgeusia
5%
Aspartate aminotransferase increased
5%
Upper respiratory tract infection
5%
Blood creatine phosphokinase increased
5%
Type 2 diabetes mellitus
5%
Pruritus generalised
3%
Acute kidney injury
3%
Blood urea increased
3%
Lactic acidosis
3%
Dehydration
3%
Cholecystitis acute
3%
Infectious pleural effusion
3%
Tubular breast carcinoma
3%
Seizure
3%
Mental status changes
3%
Myalgia
3%
Abdominal pain upper
3%
Pyrexia
3%
Hypovolaemia
3%
Shock
3%
Blood insulin increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Incretin Based Therapy (Randomized Group)
Baseline Insulin (BL) (Non-randomized Group)
Insulin (Randomized Group)
Oral Antidiabetic Drugs (OAD) (Non-randomized Group)
No OAD (Non-randomized Group)

PASIPHY Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Pasireotide s.c. 50 mcgExperimental Treatment1 Intervention
Pasireotide 50 mcg s.c. tid
Group II: Pasireotide 200 mcgExperimental Treatment1 Intervention
Pasireotide 200 mcg s.c. tid
Group III: Pasireotide 100 mcgExperimental Treatment1 Intervention
Pasireotide 100 mcg s.c. tid
Group IV: PlaceboPlacebo Group1 Intervention
Placebo s.c. tid

Find a Location

Who is running the clinical trial?

RECORDATI GROUPLead Sponsor
12 Previous Clinical Trials
4,385 Total Patients Enrolled
Arnd H Mueller, MDStudy DirectorRecordati AG
Arnd H MUELLER, MDStudy DirectorRecordati AG
~46 spots leftby Apr 2025
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