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Safety, Tolerability and Efficacy Study of PP1420 in HV

NCT02221765 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-09-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PP1420

Single dose of PP 1420, administered subcutaneously. Dose levels: 8, 16, 32, 64 mg.

DRUG

Placebo

0.9% (w/v) saline single-dose, administered subcutaneously

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Stephen Bloom · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02221765 on ClinicalTrials.gov