Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Individualized Obesity Pharmacotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03374956
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Andres J. Acosta, M.D., Ph.D., Mayo Clinic

Brief Summary:
The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.

Condition or disease Intervention/treatment Phase
Obesity Drug: Phentermine-Topiramate Drug: Liraglutide Drug: Naltrexone/bupropion Drug: Phentermine Phase 3

Detailed Description:
All participants will be phenotype and participants will randomized to randomly assigned medications vs phenotype guided medications for obesity. All participants will receive a standard intense lifestyle intervention.All participants will be seen at 4 and 12 weeks. At the 12-week visit, participants will be unblinded to their "obesity-related phenotype" and they could contact their physician to continue a FDA-approved medication as part of clinical care. Study team will prospectively follow the patients' weight, waist circumference and use of obesity medications every 3 months for 1 year.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Phentermine

Arm Intervention/treatment
Experimental: Intervention group
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Drug: Phentermine-Topiramate
Extended Release at dose of 7.5/46 mg oral daily
Other Name: Qsymia

Drug: Liraglutide
dose of 3 mg subcutaneous daily
Other Name: Saxenda

Drug: Naltrexone/bupropion
Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Other Name: Contrave

Active Comparator: Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Drug: Phentermine-Topiramate
Extended Release at dose of 7.5/46 mg oral daily
Other Name: Qsymia

Drug: Liraglutide
dose of 3 mg subcutaneous daily
Other Name: Saxenda

Drug: Naltrexone/bupropion
Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Other Name: Contrave

Drug: Phentermine
15-37.5 mg oral daily
Other Names:
  • Adipex-P
  • Lomaira




Primary Outcome Measures :
  1. Total Body Weight Loss [ Time Frame: baseline, 12 weeks ]
    Change in body weight will be measured in kilograms


Secondary Outcome Measures :
  1. Percentage of responders [ Time Frame: baseline,4 weeks, 12 weeks ]
    Percentage of participants who loss 5% or more of total body weight

  2. Percentage of responders [ Time Frame: baseline, 12 weeks, 6 months, 12 months ]
    Percentage of participants with at least 10% total body weight loss

  3. Percentage of responders [ Time Frame: baseline, 12 weeks ]
    Percentage of participants with 15% total body weight loss

  4. Percentage of responders [ Time Frame: baseline, 4 weeks, 12 weeks ]
    Percentage of participants who loss 5% or more of total body weight in each phenotype



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adults with obesity (BMI >30 Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
  • Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure.

Exclusion criteria

  • Abdominal bariatric surgery
  • Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6 months.
  • Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
  • Hypersensitivity to any of the study medications.
  • No contraindications to all FDA-approved medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374956


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Judith Davis    507-266-9447    RSTINDIVOBESITY@mayo.edu   
Principal Investigator: Andres J Acosta         
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Andres J Acosta Mayo Clinic

Additional Information:
Layout table for additonal information
Responsible Party: Andres J. Acosta, M.D., Ph.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03374956     History of Changes
Other Study ID Numbers: 17-003449
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andres J. Acosta, M.D., Ph.D., Mayo Clinic:
Pharmacological
Obesity Management
Individualized
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Liraglutide
Topiramate
Phentermine
Naltrexone
Bupropion
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Alcohol Deterrents
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors