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Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers
N/A
Recruiting
Led By Carol J Fabian, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights
No Placebo-Only Group
Summary
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.
Eligible Conditions
- Breast Cancer Risk
- Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Completion rate of 70% or more
Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months
Secondary study objectives
Assessment of GIP-R expression in breast tissue
Change in benign breast tissue estrogen response and ELF5 gene expression
Change in benign breast tissue proliferation
+2 moreSide effects data
From 2018 Phase 2 trial • 318 Patients • NCT0313168730%
Nausea
17%
Diarrhoea
11%
Nasopharyngitis
9%
Vomiting
7%
Upper respiratory tract infection
6%
Decreased appetite
6%
Constipation
6%
Hypertension
6%
Abdominal distension
4%
Dyspepsia
4%
Bronchitis
4%
Influenza
2%
Lipase increased
2%
Headache
2%
Cough
2%
Cholecystitis
2%
Back pain
2%
Cluster headache
2%
Abdominal pain upper
2%
Dizziness
2%
Coronary artery disease
2%
Contusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
1.5 mg Dulaglutide
15 mg Tirzepatide + Placebo
Placebo
1 mg Tirzepatide
5 mg Tirzepatide
10 mg Tirzepatide
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: women using tirzepatide for weight lossExperimental Treatment1 Intervention
Women attending the University of Kansas Medical Center (KUMC) Weight Management Clinic
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tirzepatide
2017
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
513 Previous Clinical Trials
176,995 Total Patients Enrolled
Carol J Fabian, MDPrincipal InvestigatorUniversity of Kansas Medical Center
13 Previous Clinical Trials
4,066 Total Patients Enrolled