Individualized Obesity Pharmacotherapy

NCT03374956 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 17-003449
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Pharmacological; Obesity Management; Individualized

Outcome Measures

Primary Outcomes (1)

• Change in Total Body Weight

  Percent change in body weight

  baseline to 12 weeks

Secondary Outcomes (2)

• Percentage of Responders

  baseline to 12 weeks

• Percentage of Responders

  baseline to 12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise

Drug: Phentermine-Topiramate; Drug: Liraglutide; Drug: Naltrexone/bupropion

Control Group

ACTIVE COMPARATOR

Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine

Drug: Phentermine-Topiramate; Drug: Liraglutide; Drug: Naltrexone/bupropion; Drug: Phentermine

Interventions

Phentermine-Topiramate DRUG

Extended Release at dose of 7.5/46 mg oral daily

Also known as: Qsymia

Control Group; Intervention group

Liraglutide DRUG

dose of 3 mg subcutaneous daily

Also known as: Saxenda

Control Group; Intervention group

Naltrexone/bupropion DRUG

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)

Also known as: Contrave

Control Group; Intervention group

Phentermine DRUG

15-37.5 mg oral daily

Also known as: Adipex-P, Lomaira

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 33759389 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity

Interventions

Qsymia; Liraglutide; Naltrexone; Bupropion; bupropion hydrochloride, naltrexone hydrochoride drug combination; Phentermine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propiophenones; Ketones; Organic Chemicals; Amphetamines; Phenethylamines; Ethylamines; Amines

Results Point of Contact

• Title: Andres Acosta
• Organization: Mayo Clinic

acosta.andres@mayo.edu

507-266-6931

Study Officials

• Andres J Acosta

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: December 15, 2017
• Study Start: December 11, 2017
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: July 18, 2023
• Results First Posted: July 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)