Safety, Tolerability and Efficacy Study of PP1420 in HV
Status:
Terminated
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
Obesity is a growing pandemic which affects 1 in 4 adults in the UK, and shortens life by
increasing cardiovascular disease, diabetes and cancer. Current treatments for obesity have
either poor efficacy or significant side effects. Pancreatic polypeptide (PP) is a promising
new drug target as it produces powerful appetite suppression which, following a 90-minute
infusion continues to act for 24 h in man. We have developed a new long lasting high potency
analogue of PP, PP1420. This is delivered as a once-a-day subcutaneous injection via a
painless fine-gauge needle.
In a first-time-in-man Phase 1a trial, that PP 1420 proved safe, well tolerated, and had
extended pharmacokinetics compared to PP itself.
We now plan to study the safety and PK of PP1420 up to 64mg. We will also assess:
1. Its efficacy in reducing food intake after a single dose in a Phase 1B study in healthy
volunteers.
2. Its efficacy in reducing food intake and weight after multiple dosing in a Phase 1C
study in healthy volunteers.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Imperial College London
Collaborators:
Imperial College Healthcare NHS Trust Wellcome Trust