A Randomized, Double-Blind, Phase 4 Study to Evaluate the Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Patients Post Bariatric Surgery
Overview
- Phase
- Phase 4
- Intervention
- Naltrexone HCl/Bupropion HCl Placebo
- Conditions
- Weight Regain Post Bariatric Surgery
- Sponsor
- Takeda
- Primary Endpoint
- Percent Change from Baseline in Body Weight at Week 26
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and bupropion hydrochloride extended release combination (NB) compared with placebo on weight loss in obese participants post bariatric surgery.
Detailed Description
The drug being tested in this study is called naltrexone hydrochloride/bupropion hydrochloride (NB). NB is being tested to determine its effect on weight loss in obese participants post bariatric surgery. The study will enroll approximately 60 participants. Participants will be randomly assigned to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Naltrexone HCl 32 mg/bupropion HCl 360 mg extended-release tablet * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient All participants will start on 1 tablet a day and will increase their dose by 1 tablet per week for 4 weeks to reach the optimal dose. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 59 weeks maximum. Participants will make multiple visits to the clinic, plus a final visit 4 weeks after last dose of study drug for a follow-up assessment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- •The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- •Is female or male and aged 18 to 65 years, inclusive.
- •Is at least 2 years post Roux-en-Y Gastric Bypass (RYGB) procedure for treatment of severe obesity prior to screening.
- •Has achieved an initial weight loss of ≥20% of their preoperative body weight, and has regained ≥10% of the total weight lost.
- •Has a body mass index (BMI) (weight \[kg\]/\[height {m}\]\^2) ≥30 kg/m\^
- •A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after the last dose of study drug.
- •Is able to speak and read English.
Exclusion Criteria
- •Has obesity of known endocrine origin (eg, untreated hypothyroidism, Cushing's syndrome) or of genetic origin.
- •Is currently using other bupropion- or naltrexone-containing products or has a history of hypersensitivity or allergies to naltrexone or bupropion.
- •Has a history of cancer that has been in remission for \<5 years prior to screening. A history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed.
- •Has a history of Type 1 or current type 2 diabetes mellitus (T2DM) diagnosis.
- •Has had a myocardial infarction within 6 months prior to screening.
- •Has a history of Class III or IV congestive heart failure, as per the New York Heart Association functional classification.
- •Has a history of angina pectoris Grade III or IV, as per the Canadian Cardiovascular Society grading scheme.
- •Has a clinical history of strokes, including ischemic and hemorrhagic strokes.
- •Has a history (within the last 20 years) of seizures, cranial trauma, active bulimia, anorexia nervosa, or other conditions that predispose the participant to seizures.
- •Has, in the judgment of the investigator, any clinically significant electrocardiogram (ECG), laboratory, hematology, physical examination, medical history, or urinalysis finding that should prohibit participation in the study.
Arms & Interventions
Group A: Placebo
Naltrexone hydrochloride (HCl)/bupropion hydrochloride (HCl) placebo-matching tablet, orally, 1 tablet in the AM, daily, during Week 1, followed by naltrexone HCl/bupropion HCl placebo-matching tablets, orally, 1 tablet in the AM and 1 in the PM, during Week 2, followed by naltrexone HCl/bupropion HCl placebo-matching tablets, orally, 2 tablets in the AM and 1 in the PM, during Week 3, followed by naltrexone HCl/bupropion HCl placebo-matching tablets, orally, 2 tablets in the AM and 2 in the PM, in Week 4 through Week 49. Participants must be re-titrated if off treatment for ≥1 week (≥7 days).
Intervention: Naltrexone HCl/Bupropion HCl Placebo
Group B: Naltrexone HCl/Bupropion HCl
Naltrexone HCl 8 mg/bupropion HCl 90 mg, tablet, orally, 1 tablet in the AM, daily, during Week 1, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg, tablets, orally, 1 tablet in the AM and 1 in the PM, during Week 2, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg, tablets, orally, 2 tablets in the AM and 1 in the PM, during Week 3, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg, tablets, orally, 2 tablets in the AM and 2 in the PM, in Week 4 through Week 49. Participants must be re-titrated if off treatment for ≥1 week (≥7 days).
Intervention: Naltrexone HCl/Bupropion HCl
Outcomes
Primary Outcomes
Percent Change from Baseline in Body Weight at Week 26
Time Frame: Baseline and Week 26
Secondary Outcomes
- Percent Change from Baseline in Body Weight at Week 52(Baseline and Week 52)
- Percentage of Participants Achieving a Loss of at Least 2%, 5%, or 10% of Baseline Body Weight at Weeks 26 and 52(Baseline and Weeks 26 and 52)
- Changes from Baseline on Obesity-Associated Cardiovascular Risk Factors at Weeks 26 and 52(Baseline and Weeks 26 and 52)
- Change from Baseline in Fasting Glucose Levels at Weeks 26 and 52(Baseline and Weeks 26 and 52)
- Change from Baseline in and Glycosylated Hemoglobin (HbA1c) Levels at Weeks 26 and 52(Baseline and Weeks 26 and 52)
- Change from Baseline in Vital Signs at Weeks 26 and 52(Baseline and Weeks 26 and 52)
- Change from Baseline in Quality of Life as Measured by the Impact of Weight on Quality of Life Questionnaire - Lite Version (IWQOL-Lite) at Weeks 26 and 52(Baseline and Weeks 26 and 52)