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Weight Loss With Exenatide Treatment

Primary Purpose

Obesity

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Exenatide

Placebo

Dietary counseling

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Exenatide, Diet, Women

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exenatide

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Body Weight

Change in body weight after 12 weeks of treatment with exenatide or placebo twice daily injections. This outcome compares baseline and 12 week body weight.

Secondary Outcome Measures

Full Information

NCT ID

NCT01590433

First Posted

February 24, 2012

Last Updated

June 18, 2021

Sponsor

Jody Dushay

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01590433

Brief Title

Weight Loss With Exenatide Treatment

Official Title

A Prospective Study of Patterns, Predictors, and Mechanisms of Weight Loss With Exenatide Treatment in Overweight and Obese Women Without Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

January 2019 (Actual)

Study Completion Date

January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jody Dushay

Collaborators

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Overweight, Exenatide, Diet, Women

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

249 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exenatide

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Exenatide

Intervention Description

Subjects will inject 5mcg of exenatide subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subjects will inject 5mcg of identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.

Intervention Type

Behavioral

Intervention Name(s)

Dietary counseling

Intervention Description

All subjects will also receive individualized dietary counseling. Subjects in the placebo group will be counseled to follow a hypocaloric diet.

Primary Outcome Measure Information:

Title

Change in Body Weight

Description

Change in body weight after 12 weeks of treatment with exenatide or placebo twice daily injections. This outcome compares baseline and 12 week body weight.

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eleftheria Maratos-Flier, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34867786

Citation

Rodgers M, Migdal AL, Rodriguez TG, Chen ZZ, Nath AK, Gerszten RE, Kasid N, Toschi E, Tripaldi J, Heineman B, Phan M, Ngo L, Maratos-Flier E, Dushay J. Weight Loss Outcomes Among Early High Responders to Exenatide Treatment: A Randomized, Placebo Controlled Study in Overweight and Obese Women. Front Endocrinol (Lausanne). 2021 Nov 17;12:742873. doi: 10.3389/fendo.2021.742873. eCollection 2021.

Results Reference

derived

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Weight Loss With Exenatide Treatment

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