Phase II, multicentre, double blind, placebo controlled, parallel group, dose ranging study of ATL-962 (cetilistat) to assess weight loss, safety and tolerability in obese patients with Type II diabetes being treated with metformin, in comparison with orlistat

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62647464

Enrollment

600

Registered

2005-09-16

Start date

2004-12-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Obesity in patients with Type II diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes

Interventions

ATL-962 (40 mg, 80 mg, or 120 mg), or placebo, or orlistat (120 mg) three times a day for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type II diabetic patients 2. Aged 18-65 3. Body Mass Index (BMI) between 28 kg/m2 and 45 kg/m2 4. Glycosylated haemaglobin (HbA1c) value between 6% and 10% 5. Being treated with a stable dose of metformin

Exclusion criteria

Exclusion criteria: 1. Significant weight loss in the previous 3 months 2. Weight gain during the run-in period 3. Other serious systemic disease, except for controlled hypertension, mild asthma, and primary hypothyroidism 4. History of GI disorders 5. Previous surgery for weight loss

Design outcomes

Primary

Measure	Time frame
Absolute weight loss compared to baseline	—

Secondary

Measure	Time frame
Proportion of patients achieving 5% or 10% weight loss; changes in waist circumference; changes in lipid profiles; changes in markers of diabetes; incidence of GI adverse events; changes in other safety parameters	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026