Trial · Interventional

CompletedPhase 4Results postedRegistry data

Weight Loss With Exenatide Treatment

NCTNCT01590433Other id2011P000310

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 249 participants (actual)
Sponsor: Jody Dushay · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: Mar 2012
Primary completion: Jan 2019
Completion: Jan 2019
First posted: 3 May 2012 (estimated)
Last update posted: 23 Jun 2021
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20122014201620182020

Ph 4
Weight Loss With Exenatide Treatment
NCT01590433
Mar 2012 to Jan 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

ExenatideDrug
PlaceboDrug
Dietary counselingBehavioral

Arms2

Experimental
Exenatide
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.
Placebo comparator
Placebo
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Body Weight
Time frame · 12 weeks
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 weeks

Change in Body Weight

Group	Value (percentage weight loss)	Spread
Exenatide	6.5	0.4
Placebo	7.5	0.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
ExenatideExenatide: Subjects will inject 5mcg of exenatide or 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.	0 / 127	0 / 127	89 / 127
PlaceboPlacebo: Subjects will inject 5mcg of exenatide or 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. Dietary counseling: All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment.	0 / 55	0 / 55	14 / 55

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

6 results

Weight Loss Outcomes Among Early High Responders to Exenatide Treatment: A Randomized, Placebo Controlled Study in Overweight and Obese Women.

Rodgers et al. 2021Frontiers in endocrinologycited by 24

PMID 34867786PMC8635796DOI 10.3389/fendo.2021.742873PUB-34867786

CC BY6 results

Download PDF See results (6)

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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