Efficacy and Safety of ATL-962 in Obese Diabetics

Multicentre Double Blind Placebo Controlled Parallel Group Dose Ranging Study of ATL-962 to Assess Weight Loss, Safety and Tolerability in Obese Patients With Type II Diabetes Being Treated With Metformin, in Comparison With Orlistat

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00156897

Enrollment

600

Registered

2005-09-12

Start date

2004-12-31

Completion date

2005-10-31

Last updated

2006-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Insulin-Dependent Diabetes Mellitus, Obesity

Keywords

Non-insulin-dependent diabetes mellitus, NIDDM, Type II diabetes, Obesity, Lipase inhibitor

Brief summary

The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients

Detailed description

Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction. In this study patients with Type II diabetes who are clinically obese will receive ATL-962 at one of three dose levels, or placebo, or orlistat (another lipase inhibitor). The study will investigate the amount of weight lost after 12 weeks' treatment and will compare the safety and tolerability profile of ATL-962 and orlistat.

Interventions

DRUGATL-962

DRUGOrlistat

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Type II diabetes * Body mass index 28-45kg/m2 * HbA1c 6%-10%

Exclusion criteria

* Significant weight loss in the previous 3 months * Weight gain during the run-in period * Other serious systemic conditions, except controlled hypertension, mild asthma, and primary hypothyroidism * History of GI disorders * Previous surgery for weight loss

Design outcomes

Primary

Measure	Time frame
Absolute weight loss compared to baseline	—

Secondary

Measure	Time frame
Changes in waist circumference	—
Changes in lipid profiles	—
Proportion of patients achieving 5% or 10% weight loss	—
Incidence of gastrointestinal adverse effects	—
Changes in other safety parameters	—
Changes in markers of diabetes	—

Countries

Denmark, Finland, Netherlands, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026