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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
A-NEW Trial Summary
This trial will study the effects of a weight loss drug and behavior intervention on weight loss in obese breast cancer survivors, and how weight loss affects biomarkers and gut microbiome.
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.Check my eligibility
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.See study design
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.
A-NEW Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 months and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 months and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with 5 percent weight loss (in SLOW-BWL)
Secondary outcome measures
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 moreOther outcome measures
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)
A-NEW 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
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
557 Previous Clinical Trials
32,845 Total Patients Enrolled
43 Trials studying Breast Cancer
4,923 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am enrolled or plan to enroll in a weight loss program or take weight loss medication.You have a serious medical condition that could make it hard to measure your weight accurately, or a condition that makes weight loss unsafe. This includes conditions like active cancer, kidney disease, liver disease, autoimmune disease, and uncontrolled high blood pressure.I am fully active or can carry out light work.I haven't taken excluded medications recently and any current meds have been stable for 3+ months.I am a woman who finished my local cancer treatment at least 3 months ago.I have been treated for diabetes with insulin or sulfonylureas in the last 3 months.My BMI is over 27 and I have hypertension, diabetes, or high cholesterol, and I weigh less than 400 lbs.I was diagnosed with early-stage breast cancer or DCIS within the last 10 years.You are struggling with alcohol, nicotine, or drug addiction, or have recently stopped taking certain medications suddenly.You have a mental health condition that is not currently stable, or you have bulimia or anorexia nervosa.
Research Study Groups:
This trial has the following groups:- Group 1: FAST-BWL
- Group 2: SLOW-BWL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What was the outcome of Contrave's FDA evaluation?
"At Power, we give Contrave a safety score of 2. This is because Phase 2 trials only have data supporting safety, and no efficacy data has been collected yet."
Answered by AI
What is the standard medical protocol for Contrave?
"Contrave has demonstrated efficacy in the treatment of attention deficit hyperactivity disorder (ADHD), seasonal affective disorder, and smoking cessation."
Answered by AI
Are there any available slots for new participants in this research project?
"That is correct, the trial information on clinicaltrials.gov does show that the study is looking for more participants. The listing was created on February 8th, 2021 and was last updated November 2nd, 2022. They are hoping to enroll 55 people total at a single site."
Answered by AI
How many people can join this trial at most?
"Yes, an analysis of the information on clinicaltrials.gov reveals that this study is still enrolling patients. This research was initially made public on February 8th, 2021 and received its most recent update November 2nd, 2022. The trial requires 55 participants from a single location."
Answered by AI
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