NCT00822705

Brief Summary

Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

3 months

First QC Date

January 13, 2009

Last Update Submit

January 13, 2009

Conditions

Anti Obesity Agent

Keywords

Appetite, energy consumption, gastrointestinal hormones

Outcome Measures

Primary Outcomes (1)

  • Energy consumption

    1 hour food consumption

Secondary Outcomes (1)

  • Appetite feelings, plasma kinetics adverse events

    adeverse events during study (3 months)

Study Arms (4)

ORAL GLP-1, TABLET

ACTIVE COMPARATOR
Drug: Placebo tablet

Oral PYY3-36

ACTIVE COMPARATOR
Drug: Placebo tablet

Oral GLP-1 plus oral PYY3-36

ACTIVE COMPARATOR
Drug: Placebo tablet

4

PLACEBO COMPARATOR
Drug: Placebo tablet

Interventions

Placebo tabletDRUG

Control arm

4ORAL GLP-1, TABLETOral GLP-1 plus oral PYY3-36Oral PYY3-36

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subjects
  • no evidence of disease
  • no history of gastrointestinal or endocrine disorders

You may not qualify if:

  • alcohol and drug abuse
  • history of gastrointestinal or endocrine disorders
  • female subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • Steinert RE, Poller B, Castelli MC, Drewe J, Beglinger C. Oral administration of glucagon-like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects. Am J Clin Nutr. 2010 Oct;92(4):810-7. doi: 10.3945/ajcn.2010.29663. Epub 2010 Aug 18.

    PMID: 20720259DERIVED

Study Officials

  • CHRISTOPH BEGLINGER, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

August 1, 2008

Primary Completion

November 1, 2008

Study Completion

January 1, 2009

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

CH(1)