Individualized Obesity Pharmacotherapy

• ClinicalTrials.gov Identifier: NCT03374956
• Recruitment Status: Active, not recruiting
• First Posted: December 15, 2017
• Last Update Posted: November 8, 2021
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Andres J. Acosta, M.D., Ph.D., Mayo Clinic

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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: July 1, 2022
• Estimated Study Completion Date: July 1, 2022

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Andres J Acosta; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Acosta A, Camilleri M, Abu Dayyeh B, Calderon G, Gonzalez D, McRae A, Rossini W, Singh S, Burton D, Clark MM. Selection of Antiobesity Medications Based on Phenotypes Enhances Weight Loss: A Pragmatic Trial in an Obesity Clinic. Obesity (Silver Spring). 2021 Apr;29(4):662-671. doi: 10.1002/oby.23120. Erratum in: Obesity (Silver Spring). 2021 Sep;29(9):1565-1566.

• Responsible Party: Andres J. Acosta, M.D., Ph.D., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03374956
• Other Study ID Numbers: 17-003449
• First Posted: December 15, 2017
• Last Update Posted: November 8, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Liraglutide; Topiramate; Phentermine; Naltrexone; Bupropion; Alcohol Deterrents; Narcotic Antagonists; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Hypoglycemic Agents; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 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; Cytochrome P-450 Enzyme Inhibitors