# Behavioral and Pharmacological Treatments to Enhance Weight Outcomes after Metabolic and Bariatric Surgery

> **NIH NIH R01** · YALE UNIVERSITY · 2021 · $693,572

## Abstract

Project Summary.
Rates of obesity and severe obesity are expected to continue to rise to alarming levels. By 2030, over 51% of
adults in the US are expected to have obesity with a 130% increase in severe obesity. These staggering rates
and projected future increases are deeply concerning given the substantial disease and economic burden of
obesity. As severe obesity rates continue to rapidly rise, the use of metabolic and bariatric surgeries (MBS) is
expected to increase. MBS is the most effective treatment for severe obesity and results in impressive acute
and long-term weight loss, as well as improvement of medical and psychosocial comorbidities. Yet, weight
outcomes are markedly variable after MBS, suggesting that surgery alone is not enough for a sizeable
subgroup with severe obesity. Weight regain after MBS is common and a major concern, particularly because
weight regain is associated with recurring or even worsening medical comorbidities. Despite the need for
ongoing obesity treatment after MBS due to the chronicity of obesity and risk for regain, there is little guidance
as to what treatment(s) should be provided based on empirical data. In fact, no prospective studies or
randomized controlled trials (RCTs) have examined the effectiveness of pharmacologic agents and very few
(and limited) RCTs have examined behavioral weight loss (BWL) to enhance weight losses following MBS.
Thus, rigorous RCTs combining pharmacological and manualized BWL treatment to enhance weight outcomes
after MBS is an imperative next step to reduce personal and public health costs of obesity. To help fill this
critical gap in the MBS field, the proposed RCT will test the effectiveness of a rigorous manualized BWL and a
FDA-approved weight-loss agent (naltrexone+bupropion/NB), alone and in combination, for improvements in
weight loss, cardiovascular risk factors, and psychosocial functioning. N=160 patients with obesity (BMI≥30 or
≥27 with a medical comorbidity) who underwent MBS and have suboptimal weight outcomes will be randomly
assigned (double-blind) in balanced factorial (2 X 2) design, to one of four 24-week conditions: BWL+NB,
BWL+Placebo, NB-only (No BWL), or Placebo-only (No BWL). Outcome variables were determined based on
the leading rigorous weight loss RCTs for obesity with NB, NIH ADOPT guidelines, and conceptually-relevant
variables for NB and BWL. Independent outcome assessments will determine outcomes after discontinuation
of treatments through 18 months. The proposed RCT will provide important new clinical findings regarding the
utility and effectiveness of pharmacotherapy and BWL for a rapidly growing obesity subgroup and will inform
care models for managing chronic obesity to enhance outcomes after MBS. This will be the first RCT to 1) test
any pharmacologic treatment for obesity after MBS; 2) examine BWL and NB, alone and in combination, for
weight loss and associated features in patients who have undergone MBS; and 3) examine the durability of
t...

## Key facts

- **NIH application ID:** 10209694
- **Project number:** 1R01DK125650-01A1
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** VALENTINA IVEZAJ
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $693,572
- **Award type:** 1
- **Project period:** 2021-07-19 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10209694

## Citation

> US National Institutes of Health, RePORTER application 10209694, Behavioral and Pharmacological Treatments to Enhance Weight Outcomes after Metabolic and Bariatric Surgery (1R01DK125650-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10209694. Licensed CC0.

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