Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects
Public ClinicalTrials.gov record NCT01764386. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Open-Label, Controlled, Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects (The Ignite Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).
Study identification
- NCT ID
- NCT01764386
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 242 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2013 (Type not available)
- Primary completion
- Sep 2014 (Actual)
- Completion
- Sep 2014 (Actual)
- Last update posted
- Dec 29, 2015
2013 – 2014
United States locations
- U.S. sites
- 15
- U.S. states
- 8
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radiant Research | Denver | Colorado | 80239 | — |
| Radiant Research, Inc. | St Louis | Missouri | 63151 | — |
| PMG Research of Raleigh | Cary | North Carolina | 27518 | — |
| PMG Research of Winston-Salem | Hickory | North Carolina | 28601 | — |
| PMG Research of Raleigh | Raleigh | North Carolina | 27609 | — |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | — |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | — |
| Radiant Research-Akron | Akron | Ohio | 44311 | — |
| Radiant Research, Inc. | Columbus | Ohio | 43212 | — |
| Radiant Research | Anderson | South Carolina | 29621 | — |
| Radiant Research, Greer | Greer | South Carolina | 29651 | — |
| PMG Research of Charleston | Mt. Pleasant | South Carolina | 29464 | — |
| PMG Research of Bristol | Bristol | Tennessee | 37620 | — |
| Radiant Research Dallas-North | Dallas | Texas | 75231 | — |
| Radiant Research, SLC | Salt Lake City | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01764386, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 29, 2015 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01764386 live on ClinicalTrials.gov.