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GLP-1 receptor agonist

Orlistat for Obesity (EMPOWER-T2D Trial)

Phase 4
Waitlist Available
Led By Bartolome Burguera
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

EMPOWER-T2D Trial Summary

This trial is comparing an obesity-centric approach with and without AOM therapy to the current usual care approach to general health management in 300 subjects.

Eligible Conditions
  • Obesity
  • Type 2 Diabetes

EMPOWER-T2D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in A1C
Change in body weight
Efficacy of medication
+9 more

EMPOWER-T2D Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Obesity-centric approach without AOMExperimental Treatment1 Intervention
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Group II: Obesity-centric approach + AOMExperimental Treatment5 Interventions
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
Group III: Usual care approach (Comorbidity-centric approach)Active Control1 Intervention
Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Orlistat
2022
Completed Phase 4
~1490
liraglutide 3.0 mg
2016
N/A
~30

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,366,007 Total Patients Enrolled
30 Trials studying Obesity
26,229 Patients Enrolled for Obesity
Bartolome Burguera5.03 ReviewsPrincipal Investigator - Institute Chairman
The Cleveland Clinic
5Patient Review
I had such a positive experience with Dr. Buerguera today. He was kind, patient, and attentive — really listening to everything I had to say. I felt like I learned a lot from him and am so grateful for his knowledge and care.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has the necessary qualifications to be part of this research?

"This clinical trial is currently enrolling 69 individuals, aged 18 to 75 years old, who have type 2 diabetes mellitus. In addition to this criteria, participants must also be employees or the significant other of an employee with coverage in Cleveland Clinic's Employee Health Plan. All genders and ethnicities are welcome to apply."

Answered by AI

To what extent has enrollment for this trial been successful?

"At this juncture, no further participants are needed for the study that was published on September 1st 2020 and most recently revised on November 3rd 2022. Nevertheless, if you're exploring other studies with relevance to type 2 diabetes mellitus, there exist 2303 trials recruiting patients while Orlistat has 114 open clinical studies."

Answered by AI

Has Orlistat been sanctioned by the Food and Drug Administration?

"The safety of orlistat has been established via a Phase 4 trial, which warranted the drug a score of 3."

Answered by AI

Are there any opportunities available to participate in this clinical experiment?

"This trial is no longer recruiting participants, with its posting and last update on the 1st of September 2020 and 3rd of November 2022 respectively. If you are seeking out other clinical trials, there are currently 2303 studies actively searching for patients afflicted by type 2 diabetes mellitus, as well as 114 that are looking for individuals to test Orlistat's efficacy."

Answered by AI

Are adults aged 25 or more able to partake in this research?

"This trial has a cut-off age of 75 years old, with all participants needing to be of legal age (18 or above)."

Answered by AI

What is the common medical application of Orlistat?

"Orlistat, a clinically approved therapeutic agent, is effective at managing weight gain, diabetes and ADHD."

Answered by AI

Who else is applying?

What state do they live in?
North Dakota
Ohio
How old are they?
18 - 65
65+
What site did they apply to?
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial
Bartolome Burguera 2020. "EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04531176.
All > Type 2 Diabetes > Xenical
~15 spots leftby Apr 2025
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