WithdrawnPhase 4

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

United States0Started 2016-02

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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\^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.

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.

What they're measuring

Percent Change from Baseline in Body Weight at Week 26

Timeframe: Baseline and Week 26

Trial details

NCT IDNCT02616315

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10

View on ClinicalTrials.gov More Weight Regain Post Bariatric Surgery trials