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Completed

NCT Number: NCT00156897

Efficacy and Safety of ATL-962 in Obese Diabetics

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

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Key information

Conditions

Non-Insulin-Dependent Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aalborg Sygehus Nord, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATL-962

Drug

Orlistat

Drug

Primary outcomes

  1. Absolute weight loss compared to baseline

Secondary outcomes

  1. Proportion of patients achieving 5% or 10% weight loss

  2. Changes in waist circumference

  3. Changes in lipid profiles

  4. Changes in markers of diabetes

  5. Incidence of gastrointestinal adverse effects

  6. Changes in other safety parameters

Sponsors and collaborators

Lead sponsor

Alizyme

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Aug 29, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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