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Anti-obesity agent

Drug + Behavioral Weight Loss for Obesity (A-NEW Trial)

Phase 2
Waitlist Available
Led By Jennifer Sheng
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 months and 6 months
Awards & highlights

Summary

This trial tests a weight loss medication and a remote coaching program to help overweight or obese breast cancer survivors lose weight. Participants receive phone support from a coach, and those who don't lose enough weight will start taking the medication. The study aims to see if this approach helps with weight loss and improves health markers.

Who is the study for?
This trial is for female breast cancer survivors who are overweight or obese, finished local therapy at least 3 months ago, and have not had any serious medical conditions that could affect weight measurement. They must be willing to change their diet and exercise habits, track behaviors, attend regular contacts and visits, take a chronic weight loss medication, and have stable internet access.
What is being tested?
The A-NEW Study is testing the combination of a drug called Contrave with a remote behavioral weight loss program to see if they help in losing weight. It also looks at how this weight loss might change certain blood markers and gut bacteria in these women.
What are the potential side effects?
Possible side effects from Contrave include nausea, constipation, headache, vomiting, dizziness, trouble sleeping (insomnia), dry mouth and diarrhea. The behavioral intervention may cause changes in mood or behavior due to lifestyle adjustments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with 5 percent weight loss (in SLOW-BWL)
Secondary study objectives
Change in Adiponectin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to
Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss
Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss
+53 more
Other study objectives
Number of participants with AA genotype and 5% weight loss
Number of participants with AA genotype and Contrave
Number of patients with 5% weight loss (in FAST-BWL)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SLOW-BWLExperimental Treatment2 Interventions
All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose \<5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave \[as per the Food and Drug Administration (FDA) recommended administration\] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6.
Group II: FAST-BWLActive Control1 Intervention
All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contrave
2017
Completed Phase 4
~90
Behavioral Weight Loss
2011
N/A
~320

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer include hormone therapy, chemotherapy, and targeted therapy. Hormone therapy blocks hormones that fuel cancer growth, chemotherapy kills rapidly dividing cells, and targeted therapy focuses on specific cancer-related molecules. The A-NEW study's combination of pharmacotherapy and behavioral weight loss interventions aims to improve overall health, potentially enhancing treatment efficacy by reducing inflammation and improving metabolic health, which is crucial for breast cancer patients.

Find a Location

Who is running the clinical trial?

Wellspan-Hopkins Cancer Health Services Research FundUNKNOWN
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
566 Previous Clinical Trials
33,321 Total Patients Enrolled
44 Trials studying Breast Cancer
4,953 Patients Enrolled for Breast Cancer
American Institute for Cancer ResearchOTHER
10 Previous Clinical Trials
8,506 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer

Media Library

Contrave (Anti-obesity agent) Clinical Trial Eligibility Overview. Trial Name: NCT04499950 — Phase 2
Breast Cancer Research Study Groups: FAST-BWL, SLOW-BWL
Breast Cancer Clinical Trial 2023: Contrave Highlights & Side Effects. Trial Name: NCT04499950 — Phase 2
Contrave (Anti-obesity agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04499950 — Phase 2
~12 spots leftby Sep 2025
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