CompletedNCT03374956Updated Jul 18, 2023Results posted

Individualized Obesity Pharmacotherapy

A Phase 3 interventional study of Phentermine-Topiramate and Liraglutide in Obesity, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-18.

Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 193
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Obesity

Browse trials for

Obesity 6,243

Keywords

Pharmacological
Obesity Management
Individualized

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 193 participants (actual)

Study arms

Experimental
Intervention group
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Drug: Phentermine-Topiramate · Drug: Liraglutide · Drug: Naltrexone/bupropion
Active comparator
Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Drug: Phentermine-Topiramate · Drug: Liraglutide · Drug: Naltrexone/bupropion · Drug: Phentermine

Interventions

DrugPhentermine-Topiramate
Extended Release at dose of 7.5/46 mg oral daily
Also known as: Qsymia
DrugLiraglutide
dose of 3 mg subcutaneous daily
Also known as: Saxenda
DrugNaltrexone/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)
Also known as: Contrave
DrugPhentermine
15-37.5 mg oral daily
Also known as: Adipex-P, Lomaira

What researchers measure

Primary outcomes

Change in Total Body Weight
Percent change in body weight
Time frame: baseline to 12 weeks

Secondary outcomes

Percentage of Responders
Percentage of participants who loss 5% or more of total body weight
Time frame: baseline to 12 weeks
Percentage of Responders
Percentage of participants with at least 10% total body weight loss
Time frame: baseline to 12 weeks

Results

Posted Jul 18, 2023

Participant flow

Participant flow — Overall Study
Milestone	Intervention Group	Control Group
Started	93	100
Completed	93	100
Not completed	0	0

Outcome measures

PrimaryChange in Total Body Weight

Percent change in body weight

Time frame:: baseline to 12 weeks
Reported as:: Median · percent change

Change in Total Body Weight
percent change	Intervention Group	Control Group
Change in Total Body Weight	-7.7 (-11 to -4.7)	-6.5 (-11 to -2.3)

SecondaryPercentage of Responders

Percentage of participants who loss 5% or more of total body weight

Time frame:: baseline to 12 weeks
Reported as:: Number · percentage of participants

Percentage of Responders
percentage of participants	Intervention Group	Control Group
Percentage of Responders	81	80

SecondaryPercentage of Responders

Percentage of participants with at least 10% total body weight loss

Time frame:: baseline to 12 weeks
Reported as:: Number · percentage of participants

Percentage of Responders
percentage of participants	Intervention Group	Control Group
Percentage of Responders	44	40

Adverse events

Collected over Baseline to 12 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Intervention Group	0/93 (0%)	0/93 (0%)	23/93 (24.7%)
Control Group	0/100 (0%)	0/100 (0%)	25/100 (25%)

Most frequent other events

Most frequent other events
Event	Intervention Group	Control Group
During studyGastrointestinal disorders	23/93	25/100

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Intervention Group	Control Group	Total
<=18 years	0	0	0
Between 18 and 65 years	93	100	193
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Intervention Group	Control Group	Total
Mean	38.5 ± 16	39 ± 14	39 ± 15

Sex: Female, Male
Sex: Female, Male(Participants)	Intervention Group	Control Group	Total
Female	65	78	143
Male	28	22	50

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Intervention Group	Control Group	Total
American Indian or Alaska Native	0	0	0
Asian	2	1	3
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	2	2
White	88	87	175
More than one race	0	0	0
Unknown or Not Reported	3	10	13

Region of Enrollment
Region of Enrollment(Participants)	Intervention Group	Control Group	Total
United States	93	100	193

Study locations

1 site

Mayo Clinic in Rochester
Rochester, Minnesota 55905, United States

References and documents

Publications

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. doi: 10.1002/oby.23236. Obesity (Silver Spring). 2022 Jul;30(7):1521. doi: 10.1002/oby.23498. PubMed 33759389 ↗

Study documents

Protocol and statistical analysis plan · May 18, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03374956
Lead sponsor: Mayo Clinic
Responsible party: Andres J. Acosta, M.D., Ph.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted: Dec 15, 2017
Start date: Dec 11, 2017
Primary completion: May 26, 2022
Completion: May 26, 2022
Results posted: Jul 18, 2023
Last update: Jul 18, 2023

Study contacts

Andres J Acosta

principal investigator · Mayo Clinic

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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