Naltrexone/Bupropion With or Without Very Low Calorie Ketogenic Diet for Weight Regain After Bariatric Surgery

NCT ID: NCT06881485

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2027-01-01

Brief Summary

The goal of this clinical trial is to evaluate the superiority of combined VLCKD, intensive lifestyle intervention and naltrexone/bupropion (N/B) versus standard of care with naltrexone/bupropion on weight loss for people with weight regain after bariatric surgery.

The main questions it aims to answer are:

Primary endpoint:

• The percentage of weight loss at 26 weeks

Secondary endpoints:

• A weight loss percentage at 10 weeks, 16 weeks and at end of trial (= 52 weeks from start)
• A proportion of patients with a weight loss percentage of 5% or more at 10, 16, 26 and 52 weeks
• A proportion of patients with a weight loss percentage of 10% or more at 10, 16, 26 and 52 weeks
• The time to reach a weight loss percentage of 5% and 10%
• The dose of naltrexone/bupropion used at 10, 16, 26 and 52 weeks and at the end of the trial
• The tolerability of VLCKD and NB
• The adherence to VLCKD and NB
• The Patient-Reported Outcome Measures (PROMs) of hunger and cravings at 0, 4, 10, 16, 26 and 52 weeks
• The change in fasting glucose, lipids and blood pressure at 10, 16, 26 and 52 weeks

Researchers will compare an experimental arm (N/B + Lifestyle + VLCKD) with comparator arm (NB + lifestyle) to see if combined VLCKD, intensive lifestyle and N/B is superior.

Participants will:

• get NB and lifestyle changes for 26 weeks
• follow a VLCKD in the first 10 weeks on top of it, if they belong to the experimental arm
• follow NB combined with lifestyle the remaining 16 weeks
• be followed-up for an extension of 26 weeks
• come to the hospital at week 1, 10, 16, 26, 52

Conditions

Weight Regain Post Bariatric Surgery; Obesity (Disorder)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Naltrexon/Bupropion + Lifestyle + VLCKD

Naltrexon/Bupropion + Lifestyle + VLCKD

Group Type: EXPERIMENTAL

Very Low Calorie Diet

Intervention Type: OTHER

This is a parallel multicentric longitudinal randomized controlled trial in which prospective data will be collected from the electronic health record. The inclusion and exclusion criteria will be checked and afterwards patients will be randomized to (unblinded) medication only or combination with VLCKD. Both arms include NB and lifestyle changes for 26 weeks but the patients belonging to the experimental arm must follow a VLCKD in the first 10 weeks on top of it. Like the other arm, the remaining 16 weeks will consist of NB combined with lifestyle interventions. Afterwards there is a follow-up extension of 26 weeks.

Naltrexon/Bupropion + Lifestyle

Naltrexon/Bupropion + Lifestyle

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Very Low Calorie Diet

This is a parallel multicentric longitudinal randomized controlled trial in which prospective data will be collected from the electronic health record. The inclusion and exclusion criteria will be checked and afterwards patients will be randomized to (unblinded) medication only or combination with VLCKD. Both arms include NB and lifestyle changes for 26 weeks but the patients belonging to the experimental arm must follow a VLCKD in the first 10 weeks on top of it. Like the other arm, the remaining 16 weeks will consist of NB combined with lifestyle interventions. Afterwards there is a follow-up extension of 26 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants eligible for inclusion in this Trial must meet all of the following criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures

2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.

3. Miminum 18 years of age at the time of Informed Consent signature

4. Underwent bariatric surgery (RYGB or SG) with weight regain ≥10% of nadir weight

5. People without Type 2 diabetes (T2D) • No history, no drugs, HbA1c < 6,5% and FPG <126 mg/dl) All participants that are considered for Trial participation, per the above criteria will be documented on the Screening Log, including Screen Failures.

Exclusion Criteria

• Participants eligible for this Trial must not meet any of the following criteria:

1. Participant has a history of type 2 diabetes mellitus (also drugs, HbA1c > 6,5% and FPG >126 mg/dl)

2. IFemale who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive

3. Participation in an interventional Trial with an investigational medicinal product (IMP) or device

4. Not willing to sign informed consent

5. Younger than 18 years of age at the time of Informed Consent signature

6. Other types of bariatric surgery other than RYGB or SG (including LAGB, BPD)

7. Underwent bariatric surgery (RYGB or SG) with weight regain <10% of nadir weight

8. Contraindication for VLCKD, including CKD stage 4-5, liver cirrhosis, type 1 diabetes mellitus, active gout

9. Contraindication for NB including the use of opioids, history of CNS tumor or seizures, severe psychiatric disorder or > 2 psychotropic medications, uncontrolled hypertension

10. Use of other drugs for weight management (e.g. GLP1Ra) in the last 3 months prior to trial intervention

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

AZ Sint-Jan Brugge

Bruges, West-Vlaanderen, Belgium

Site Status: NOT_YET_RECRUITING

Countries

Belgium

Central Contacts

Prof. Dr. R. Vangoitsenhoven

Role: CONTACT

relaytrial@uzleuven.be

+3216344775

Facility Contacts

Prof. Dr. R. Vangoitsenhoven

Role: primary

relaytrial@uzleuven.be

+3216344775

Dr. B. Dillemans

Role: primary

obesitascentrum@azsintjan.be

+3250452553

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

S68952

Identifier Type: -

Identifier Source: org_study_id