Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults

Roche

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: Orlistat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02706067

ML16868

Details and patient eligibility

About

This study will evaluate the efficacy of a multifactorial approach associated with orlistat (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination with diet, physical activity, and/or cognitive behavioral therapy will be monitored.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) greater than or equal to (>/=) 30 kilograms per meter-squared (kg/m^2), or BMI >/= 28 kg/m^2 with risk factors of diabetes, hypertension, or hyperlipidemia, before weight loss
• Documented weight loss >/= 10% of initial body weight obtained with diet, with or without psychological therapy or orlistat

Exclusion criteria

• Pregnant or lactating females
• History or presence of significant medical disorders
• Active gastrointestinal disorders such as peptic ulcer disease or malabsorption syndromes
• Pancreatic disease: pancreatic enzyme deficiency, history or current presence of pancreatitis
• Clinically significant abnormal clinical chemistry or hematology results
• Excessive alcohol intake
• Smoking cessation within the previous 6 months
• History or presence of cancer
• Administration of medicines known to alter body weight
• History or presence of cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Orlistat

Experimental group

Description:

Participants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes.

Treatment:

Drug: Orlistat