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Use of Mysimba in Patients With Weight Regain After Bariatric Surgery

NCT04902625 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2023-05-30

No results posted yet for this study

Summary

Although bariatric surgery is currently the most effective treatment for morbid obesity, weight regain occurs in 16-37% of the patients (1). Weight regain is not regularly treated with antiobesity medications (AOMs).

Mysimba (Contrave in US) is a AOM, it is a combination of naltrexone hydrochloride extended release and bupropion hydrochloride extended release for the treatment of obesity, and is used with lifestyle modification. Bupropion is a mild reuptake inhibitor of dopamine and norepinephrine. Naltrexone, an opioid antagonist has minimum effect on weight loss on its own. Naltrexone is thought to block the inhibitory effects of opioid receptors activated by the β-endorphin released in the hypothalamus that stimulates feeding, thus allowing the inhibitory effects of α-melanocyte stimulating hormone to reduce food intake. In patients with obesity usage of Naltrexone/Bupropion (NB) results in up to 8.2% weight loss (2). There is some evidence that also in bariatric patients with weight regain NB leads to additional weight loss (3, 4).

At the Nederlandse Obesitas Kliniek (NOK) weight regain at follow-up is currently treated with the Back on Track (BOT) program. The BOT program is an extra intervention our clinic provides for the patients who have weight regain after surgery, this is part of our standard care program.

The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss(\>5% weight loss) after 22 weeks in patients with weight regain after bariatric surgery, compared to the regular BOT module.

Conditions

  • Obesity, Morbid
  • Bariatric Surgery Candidate
  • Medication Persistence

Interventions

DRUG

Naltrexone-Bupropion Combination

Naltrexone-bupropion will be added to the BOT module in the interventional arm.

Sponsors & Collaborators

  • Nederlandse Obesitas Kliniek

    collaborator UNKNOWN

  • Zuyderland Medisch Centrum

    lead OTHER

Principal Investigators

  • Jan Willem Greve, MD, PhD, professor · Nederlandse Obesitas Kliniek Zuid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902625 on ClinicalTrials.gov