Pharmacological and Behavioral Treatment After Bariatric Surgery

NCT05157698 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 20000299341R01DK125650-01A1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

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

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 Combination; Behavioral: 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 Loss; Other: 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 Combination DRUG

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

BWL + NB medication; NB medication

Behavioral Weight Loss BEHAVIORAL

Participants in this intervention will receive behavioral weight loss treatment.

BWL + NB medication; BWL + Placebo

Placebo OTHER

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

BWL + Placebo; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Naltrexone-Bupropion combination

Condition Hierarchy (Ancestors)

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

Study Officials

• Valentina Ivezaj, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)