Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT01052493
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2010-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A First-Time-in-Human Study to Assess the Safety and Tolerability of PP 1420 in Healthy Subjects
Sponsor:
Imperial College London
Organization:
Study Overview
Official Title:
A First Time in Human, Double Blind, Randomised, Placebo Controlled Dose Escalation Study to Assess the Safety and Tolerability of PP 1420 in Healthy Subjects.
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
When humans eat, the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating. One of these chemicals is known as "Pancreatic Polypeptide" (PP). We have previously shown that injections of human PP reduces appetite and food intake. We have now developed a very similar chemical, PP 1420, as a treatment for obesity. PP 1420 has been tested in animals and has been shown to be safe, and to reduce their appetite. This study will test PP 1420 for its safety and tolerability in humans.
Detailed Description:
More than 20 percent of people in the UK are obese. People with obesity have a shorter life expectancy, and have a higher risk of having heart attacks, strokes, high blood pressure, diabetes, and certain cancers.
At the moment, there is no treatment for obesity that is both effective and safe. Advising people to change their diet and to exercise more is frequently ineffective, and any loss in weight seen is usually temporary. There are a couple of licensed medications for the purpose of losing weight, but they are limited by side effects. Finally, gastric bypass and similar surgeries are effective at reducing weight permanently, but it can be risky and is restricted only to very motivated people.
"Gut hormones" are natural chemicals made by the bowels when you eat. They work to reduce appetite and hunger when you eat, so that you will eat enough for your needs. We think that one of the reasons why gastric bypass surgery is so effective is because the surgery causes an increase in gut hormone secretion into the bloodstream, which suppresses appetite. One of these hormones is pancreatic polypeptide (PP), which is released into the bloodstream by cells in the pancreas after eating. When human PP is given to healthy volunteers as an injection, we see that they have a reduced appetite and food intake with no side effects such as feeling sick or vomiting.
Human PP does not last long in the blood stream. In order to make it into a new, safe and effective drug for obesity, we have developed a new form of PP, which is very similar but not identical to human PP, that we expect will last longer in the blood. We call this PP 1420.
In testing, PP 1420 reduced food intake in animals, and was safe in them at much higher doses than those we plan to give in the current study. This study will assess the safety and tolerability of PP 1420 in humans, and is the first time humans have been given this medication.
At the moment, there is no treatment for obesity that is both effective and safe. Advising people to change their diet and to exercise more is frequently ineffective, and any loss in weight seen is usually temporary. There are a couple of licensed medications for the purpose of losing weight, but they are limited by side effects. Finally, gastric bypass and similar surgeries are effective at reducing weight permanently, but it can be risky and is restricted only to very motivated people.
"Gut hormones" are natural chemicals made by the bowels when you eat. They work to reduce appetite and hunger when you eat, so that you will eat enough for your needs. We think that one of the reasons why gastric bypass surgery is so effective is because the surgery causes an increase in gut hormone secretion into the bloodstream, which suppresses appetite. One of these hormones is pancreatic polypeptide (PP), which is released into the bloodstream by cells in the pancreas after eating. When human PP is given to healthy volunteers as an injection, we see that they have a reduced appetite and food intake with no side effects such as feeling sick or vomiting.
Human PP does not last long in the blood stream. In order to make it into a new, safe and effective drug for obesity, we have developed a new form of PP, which is very similar but not identical to human PP, that we expect will last longer in the blood. We call this PP 1420.
In testing, PP 1420 reduced food intake in animals, and was safe in them at much higher doses than those we plan to give in the current study. This study will assess the safety and tolerability of PP 1420 in humans, and is the first time humans have been given this medication.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-017522-39 | EUDRACT_NUMBER | None | View |