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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at ways to help people who have regained weight after having bariatric surgery, which is a type of surgery to help with weight loss. The researchers want to see if combining a very low-calorie ketogenic diet (which is a high-fat, low-carb diet) with a medication called naltrexone/bupropion and lifestyle changes can help people lose more weight compared to just using the medication and lifestyle changes alone. The main goal is to measure how much weight participants lose after 26 weeks, and they will also check progress at earlier times, like 10 and 16 weeks.

To join the trial, participants should be at least 18 years old, have had bariatric surgery, and have regained at least 10% of their lowest weight. They should not have type 2 diabetes or certain other medical conditions. If eligible, participants will receive the naltrexone/bupropion treatment and lifestyle guidance for 26 weeks, with those in the experimental group following the very low-calorie diet for the first 10 weeks. Throughout the trial, participants will visit the hospital several times to monitor their progress. This trial is currently recruiting participants, and it aims to find effective ways to support weight loss after bariatric surgery.

Gender

ALL

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
• • 11. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol Participants who meet one or more of the above exclusion criteria must not proceed to be enrolled/randomized in the Trial and will be identified on the Screening Log as Screen Failure.