NCT05157698

Brief Summary

This study will compare the effectiveness of behavioral and pharmacologic treatment, alone and combined, for improvements in weight loss, cardiovascular risk factors, and psychosocial functioning following metabolic and bariatric surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
20mo left

Started Jan 2022

Longer than P75 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2022Jan 2028

First Submitted

Initial submission to the registry

November 22, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

January 13, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2028

Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

November 22, 2021

Last Update Submit

June 17, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Change in Body Mass Index (BMI)

    BMI is calculated using measured height and weight

    Baseline to after the 6-month treatment

  • Change in Body Mass Index (BMI)

    BMI is calculated using measured height and weight

    From post-treatment (6-months) to the 12-month follow-up

Secondary Outcomes (14)

  • Change in Total cholesterol

    From baseline at study enrollment to after the 6-month treatment

  • Change in Total cholesterol

    From post-treatment (6-months) to the 12-month follow-up

  • Change in HbA1C

    From baseline at study enrollment to after the 6-month treatment

  • Change in HbA1C

    From post-treatment (6-months) to the 12-month follow-up

  • Change in Glucose

    From baseline at study enrollment to after the 6-month treatment

  • +9 more secondary outcomes

Study Arms (4)

BWL + NB medication

EXPERIMENTAL

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.

Drug: Naltrexone and Bupropion CombinationBehavioral: Behavioral Weight Loss

BWL + Placebo

EXPERIMENTAL

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.

Behavioral: Behavioral Weight LossOther: Placebo

NB medication

EXPERIMENTAL

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

Drug: Naltrexone and Bupropion Combination

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Naltrexone and Bupropion CombinationDRUG

Participants in this intervention will take active naltrexone and bupropion pills.

BWL + NB medicationNB medication
Behavioral Weight LossBEHAVIORAL

Participants in this intervention will receive behavioral weight loss treatment.

BWL + NB medicationBWL + Placebo
PlaceboOTHER

Participants in this intervention will take inactive (placebo) pills.

BWL + PlaceboPlacebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study (up to 18 months: 6-month treatment plus 12-month follow up)
  • Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and BMI ≤50 kg/m2
  • Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
  • Suboptimal weight outcomes after MBS
  • Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).
  • Have had a physical in the past year
  • Read, comprehend, and write English at a sufficient level to complete study-related materials.
  • For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

You may not qualify if:

  • Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
  • Has a history of anorexia nervosa or history of bulimia nervosa.
  • Is currently taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates).
  • Is currently using other medications for weight loss.
  • Has a history of allergy or sensitivity to bupropion or naltrexone.
  • Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
  • Has untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute.
  • Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.
  • Has current uncontrolled hypertension.
  • Has current uncontrolled Type I or Type 2 diabetes mellitus.
  • Has untreated hypothyroidism with a TSH \> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit.
  • Has gallbladder disease.
  • Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder.
  • Has a recent history of drug or alcohol dependence.
  • Is currently in active effective treatment for eating or weight loss such as behavioral weight loss of FDA-approved weight loss medications.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Naltrexone-Bupropion combination

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Valentina Ivezaj, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Ivezaj, Ph.D.

CONTACT

203-785-7210valentina.ivezaj@yale.edu

Carlos M Grilo, Ph.D.

CONTACT

203-785-7210carlos.grilo@yale.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 15, 2021

Study Start

January 13, 2022

Primary Completion (Estimated)

January 12, 2027

Study Completion (Estimated)

January 12, 2028

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)