Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Participants Post Bariatric Surgery

NCT02616315 | Withdrawn Phase 4

• 2 other identifiers: NaltrexBuprop-4004U1111-1168-9817
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Weight Regain Post Bariatric Surgery

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in Body Weight at Week 26

  Baseline and Week 26

Secondary Outcomes (7)

• 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

Study Arms (2)

Group A: Placebo

PLACEBO COMPARATOR

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).

Drug: Naltrexone HCl/Bupropion HCl Placebo

Group B: Naltrexone HCl/Bupropion HCl

EXPERIMENTAL

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).

Drug: Naltrexone HCl/Bupropion HCl

Interventions

Naltrexone HCl/Bupropion HCl Placebo DRUG

Naltrexone/bupropion placebo-matching tablets

Group A: Placebo

Naltrexone HCl/Bupropion HCl DRUG

Naltrexone HCl 8 mg/bupropion HCl 90 mg tablets

Group B: Naltrexone HCl/Bupropion HCl

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\^2.
• 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.

You may not qualify if:

• 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.
• Has uncontrolled hypertension defined as blood pressure (BP) ≥145/95 mm Hg at screening. BP will be measured on 2 separate occasions with an approximate 30-minute interval between measurements at the screening visit.
• Has a thyrotropin (thyroid stimulating hormone -TSH) value outside the normal range at the screening visit; unless there is a normal triiodothyronine (T3) value.
• Had initiation or alteration of dose of antihypertensive or lipid-lowering agents within 4 weeks prior to screening.
• Used prescribed or over-the-counter drugs intended for weight loss, or participated in a weight loss program other than standard of care for a post bariatric population, within 3 months prior to randomization.
• Has prior or planned surgical or device intervention for obesity except for the required RYGB Surgery.

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Study Officials

• Medical Director US Medical Affairs

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

US (2)