Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/09/2005
Date assigned
16/09/2005
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lawrence Galitz

ORCID ID

Contact details

SFBC International
Inc
11190 Biscayne Boulevard
Miami
FL 33181
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ATL-962/191/CL

Study information

Scientific title

Acronym

Study hypothesis

What are the pharmacokinetics of the metabolites of ATL-962 and what effect does ATL-962 have on faecal fat excretion in obese subjects

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Obesity

Intervention

ATL-962 40 mg, 80 mg, 120 mg or 240 mg three times a day for 14 days

Intervention type

Drug

Phase

Not Specified

Drug names

ATL-962

Primary outcome measures

Pharmacokinetics of the metabolites of ATL-962, namely ATL-1143 and ATL1277

Secondary outcome measures

Change from baseline in faecal fat excretion.
Safety and tolerability

Overall trial start date

01/04/2005

Overall trial end date

31/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Obese, otherwise-healthy, subjects, aged 18-40, with a body mass index between 30 kg/m2 and 45 kg/m2.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

1. Women who are pregnant or breast feeding
2. Any drug treatment within 2 weeks of commencement of dosing in this study

Recruitment start date

01/04/2005

Recruitment end date

31/07/2005

Locations

Countries of recruitment

United States of America

Trial participating centre

SFBC International, Inc
Miami
FL 33181
United States of America

Sponsor information

Organisation

Alizyme (UK)

Sponsor details

Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom
+44 (0)1223 896 000
Medical.Information@alizyme.co.uk

Sponsor type

Industry

Website

www.alizyme.com

Funders

Funder type

Industry

Funder name

Alizyme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes