Weight Loss With Exenatide Treatment

Jody Dushay

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: Placebo; Drug: Exenatide; Behavioral: Dietary counseling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01590433

2011P000310

Details and patient eligibility

About

The investigators are conducting a study that will investigate the possible mechanisms of weight loss associated with exenatide treatment and the metabolic characteristics of high responders (i.e. subjects who achieve greater than 5% weight loss) to exenatide treatment. The investigators will also examine the magnitude and duration of weight loss among a cohort of high responders over 52 weeks of treatment, and at 3 and 6 months following treatment.

Hypothesis:

The mechanisms of weight loss with exenatide are not fully understood, and weight loss responses to exenatide are highly variable, possibly reflecting distinct metabolic parameters. By identifying and following a group of obese women who lose greater than 5% body weight after short-term exenatide treatment, the investigators can gain insights into the possible mechanisms of weight loss and assess long-term weight loss with this pharmacotherapeutic intervention.

Full description

Primary Outcomes

The primary objectives of this study is:

• To investigate possible mechanisms and patterns of weight loss with exenatide treatment, especially among individuals who have robust early weight loss (greater than 5% weight loss in 12 weeks) with exenatide.

Secondary Outcomes

Our secondary objective is to identify metabolic characteristics that predict robust response to exenatide treatment.

Outcome measurements:

• Weight
• Body composition
• Resting energy expenditure (REE)
• Mixed meal test
• Thermic effect of food
• Serum metabolic parameters
• Hunger/Nausea/Satiety visual analog scales (VAS)
• Physical activity monitoring

Study Population

The study population will be generally healthy, non-diabetic women age 18-70 years with BMI 28-48 kg/m^2.

Enrollment: 249 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females age 18-70
• BMI 28-48 kg/m^2
• Stable weight (greater than 3 kg weight gain or loss within 6 months of screening visit).
• Ability to give informed consent and follow verbal and written instructions in English.

Exclusion criteria

• Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
• Unstable heart disease as evidenced by ongoing angina
• Congestive heart failure
• Uncontrolled hypertension (BP greater than 170/100 mmHg on or off antihypertensive medication)
• Uncontrolled dyslipidemia (LDL greater than 200 or TG greater than 400 on or off lipid lowering medication)
• Tobacco, marijuana, cocaine, or intravenous drug use
• Shift workers (night shift or alternating day/night shifts)
• Gastroparesis
• Inflammatory bowel disease or irritable bowel syndrome
• Malignancy treated with chemotherapy within the past 3 years
• History of pancreatitis
• Depression requiring hospitalization or diagnosis of psychosis
• Renal insufficiency (eGFR less than 50)
• Transaminases greater than 2 times above the normal range
• Pregnancy within 6 months of the screening visit
• Lactation
• Failure to use medically approved contraceptive methods (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
• History of an eating disorder (anorexia, bulimia or laxative abuse)
• Treatment with FDA-approved or over-the-counter weight loss medication within 6 months, with the exception of Xenical if there was no weight loss
• History of gastric bypass surgery or gastric stapling
• Biochemical evidence of hyper or hypothyroidism, or new diagnosis of hypo or hyperthyroidism within 3 months of screening visit
• Previous treatment with exenatide
• Discretion of the PI

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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249 participants in 2 patient groups, including a placebo group

Exenatide

Experimental group

Description:

Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 33 percent chance of being assigned to the placebo study treatment group and a 66 percent chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling based on food logs. Subjects who receive exenatide will not be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the unblinded members of study team will know which they are receiving.

Treatment:

Drug: Exenatide

Placebo

Placebo Comparator group

Description:

Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 33 percent chance of being assigned to the placebo study treatment group and a 66 percent chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling based on food logs. Subjects who receive placebo will be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the unblinded members of the study team will know which they are receiving.

Treatment:

Behavioral: Dietary counseling

Drug: Placebo