What side effects are associated with this type of intervention?

Behavioral treatments for obesity, such as lifestyle and behavior modifications, generally have minimal side effects but can include muscle soreness or injury from increased physical activity. Pharmacologic treatments, however, come with a range of side effects. Orlistat commonly causes gastrointestinal issues like oily stools and flatulence. GLP-1 receptor agonists, such as liraglutide and semaglutide, can cause nausea, vomiting, and diarrhea. Combination drugs like phentermine-topiramate may lead to increased heart rate, insomnia, and dry mouth, while bupropion-naltrexone can cause nausea, constipation, and headache.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including semaglutide (brand name: Wegovy) and liraglutide (brand name: Saxenda). These medications have shown significant weight loss benefits in clinical trials. For instance, in the STEP trials, semaglutide demonstrated substantial weight loss compared to placebo. Additionally, lifestyle and behavioral modifications, such as dietary changes and increased physical activity, are essential components of obesity treatment. These non-pharmacologic interventions are often recommended alongside pharmacotherapy to enhance weight loss and improve overall health outcomes.

What other types of research exist?

Promising novel alternatives for obesity treatment in 2024 include: 1) Bariatric surgery, which has shown significant weight loss and improvement in metabolic conditions; 2) Technological advances such as digital health interventions and telemedicine for weight management; 3) Combination therapies involving pharmacotherapy plus procedures, though large studies on their safety and efficacy are still needed.

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Pharmacological and Behavioral Treatment for Obesity After Bariatric Surgery

Phase 2 & 3

Recruiting

Led By Valentina Ivezaj, Ph.D.

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy

Must have suboptimal weight outcomes after MBS

Must not have

Currently using other medications for weight loss

Has untreated hypertension with a seated systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg, or heart rate > 100 beats/minute

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from post-treatment (6-months) to the 12-month follow-up

Summary

This trial tests a special program and two medications to help people lose weight after weight-loss surgery. It targets patients who still struggle with obesity despite having surgery. The program helps change daily habits, while the medications reduce hunger and cravings.

Who is the study for?

This trial is for adults with obesity who've had bariatric surgery but haven't achieved desired weight loss. Participants must have a BMI between 27-50, be in good health, and willing to follow the study plan for up to 18 months. Women must use effective contraception; men should ensure contraception with partners.

What is being tested?

The study tests if combining behavioral weight loss strategies with a medication (Naltrexone and Bupropion) is more effective than either approach alone or a placebo in improving post-surgery weight loss, cardiovascular health, and mental well-being.

What are the potential side effects?

Possible side effects include nausea, constipation, headache, dry mouth from the medication combination of Naltrexone and Bupropion. Behavioral treatment generally has no side effects but requires commitment to lifestyle changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had weight loss surgery, either gastric bypass or sleeve gastrectomy.

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I haven't lost enough weight after my bariatric surgery.

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My BMI is between 30 and 50, or it's above 27 with a health condition.

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I am a man who can father children and will use contraception.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication to lose weight.

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I have high blood pressure or a fast heart rate that hasn't been treated.

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I have a history of heart or blood vessel diseases, including stroke.

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I have poor eye health.

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My high blood pressure is not under control.

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My diabetes is not currently under control.

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I have gallbladder disease.

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I am not on medications like MAOIs or opiates that would interfere with the trial drug.

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I have a history of severe kidney, liver, nerve, lung diseases, or other unstable conditions.

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My thyroid is underactive and not yet treated, confirmed by two tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from post-treatment (6-months) to the 12-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from post-treatment (6-months) to the 12-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and from post-treatment (6-months) to the 12-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Body Mass Index (BMI)

Secondary study objectives

Change in Depressive Symptoms

Change in Eating Disorder Psychopathology

Change in Food Craving

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: NB medicationExperimental Treatment1 Intervention

Participants randomly assigned to this arm will receive 6 months of NB medication taken daily in pill form.

Group II: BWL + PlaceboExperimental Treatment2 Interventions

Participants randomly assigned to this arm will receive 6 months of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.

Group III: BWL + NB medicationExperimental Treatment2 Interventions

Participants randomly assigned to this arm will receive 6 months of Behavioral Weight Loss (BWL) counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.

Group IV: PlaceboPlacebo Group1 Intervention

Participants randomly assigned to this arm will receive 6 months of placebo. Placebo will be inactive and taken daily in pill form.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Weight Loss

2011

Completed Phase 2

~380

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral treatments for obesity, such as lifestyle and behavior modifications, work by encouraging dietary changes, increasing physical activity, and providing psychological support to help patients adopt and maintain healthier habits. Pharmacologic treatments involve medications that reduce appetite, enhance satiety, or inhibit fat absorption. These approaches are crucial for obesity patients as they tackle both the behavioral and physiological factors contributing to weight gain, offering a holistic strategy for effective weight management and improved overall health.