Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)

NCT06090461 | Completed Results

• 1 other identifier: Cardiovascular Safety Study
• Study Type: observational
• Target: 31,889
• Locations: 1 country
• Sites: 1

Brief Summary

The fixed-dose combination of naltrexone 8mg and bupropion 90mg extended-release oral tablet is marketed under the trade name CONTRAVE® in the U.S. In this protocol, the investigators propose to generate real-world evidence (RWE) from electronic health records (EHR) and linked claims data to assess the cardiovascular safety of CONTRAVE® and all combined use of naltrexone and bupropion (NB) in usual clinical practice.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• The Incidence of Major Adverse Cardiovascular Events (MACE) Between Initiators of CONTRAVE®/MYSIMBA® or N&B and Initiators of Lorcaserin.

  The primary study endpoint is MACE, defined as the composite of: * Medically attended non-fatal acute myocardial infarction (AMI); * Medically attended non-fatal stroke; * Cardiovascular death.

  Up to 113 months

Study Arms (3)

Contrave/Mysimba

A fixed-dose combination of 8 milligrams (mg) of naltrexone hydrochloride (HCl) (an opioid receptor antagonist), and 90 mg of bupropion HCl (a selective neuronal re-uptake inhibitor of noradrenaline and dopamine), delivered through extended-release oral tablets.

Lorcaserin

A total of one 10 mg tablet administered orally twice daily; or one 20 mg tablet administered orally once daily. Lorcaserin was included as an active comparator to reduce bias.

Naltrexone and Bupropion (N&B)

N\&B concomitant use, ultimately as a proxy for initiation, was defined as a record for naltrexone followed by initiation of bupropion, or bupropion followed by initiation of naltrexone, within 15 days of each other.

Eligibility Criteria

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

Study Population

The primary study population includes initiators of NB or the active comparator, lorcaserin.

You may qualify if:

• Have at least one prescription for NB between September 2014 and February 2020, including concurrent prescriptions (within 15 days) for naltrexone and bupropion; or have at least one prescription for lorcaserin;
• Have at least 180 days of data available prior to cohort entry with no evidence of prescriptions or dispensings of NB or lorcaserin;
• Have at least one BMI value available in the 180 days prior to cohort entry, inclusive of the index date;
• Have documentation of at least one outpatient medical visit 180 or more days prior to cohort entry, and at least one healthcare interaction in the 180 days prior to cohort entry;
• Are at least 18 years of age on the cohort entry date.
• For the main objective, patients are not eligible if they have a diagnosis of any of the following conditions in the 180 days before the cohort entry date:
• Epilepsy;
• Bulimia;
• Anorexia nervosa;
• Surgical procedure for weight loss.

Sponsors & Collaborators

• Currax Pharmaceuticals: lead

Study Sites (1)

Currax Pharmaceuticals

Brentwood, Tennessee, 37027, United States

Location

Related Publications (1)

• Kyle M, Burns D, Murray CR, Watson H, Swaney J, Spevack S, Leonhard M, Simon M, Moynihan E, Lapane KL, Wang SV, Longo CL, Ritchey ME, Dore DD. Cardiovascular safety of fixed-dose extended-release naltrexone/bupropion in clinical practice. Obes Pillars. 2025 Feb 17;13:100169. doi: 10.1016/j.obpill.2025.100169. eCollection 2025 Mar.

  PMID: 40104005 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: SVP, Chief Medical Officer
• Organization: Currax Pharmaceuticals LLC

mkyle@curraxpharma.com

708.834.8254

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 19, 2023
• Study Start: September 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 25, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-06

Locations

US (1)