Tirzepatide for Obesity
Phase-Based Progress Estimates
Effectiveness
Safety
Obesity+2 More
Tirzepatide - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial will study the effects of Tirzepatide in people with heart failure and obesity.
Video Summary
Eligible Conditions
- Obesity
- Heart Failure With Preserved Ejection Fraction (HFpEF)
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 9 Secondary · Reporting Duration: Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)
Baseline, Week 24
Change from Baseline in 6MWD
Baseline, Week 52
Change from Baseline in Exercise Capacity as Measured by 6MWD
Change from Baseline in the KCCQ CSS
Percent Change from Baseline in Body Weight Loss
Week 120
A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category
Time to First Occurrence of HF Events
Time to First Occurrence of HF Events or All-Cause Death
Time to First Occurrence of HF Events or Cardiovascular (CV) Death
Time to Recurrent Events of HF Events
Time to Recurrent Events of HF Events and CV Death
Week 52
Percentage of Participants with New York Heart Association (NYHA) Class Change
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
5 mg Tirzepatide
16%Nasopharyngitis
13%Nausea
12%Diarrhoea
7%Dyspepsia
7%Decreased appetite
7%Vomiting
6%Constipation
5%Back pain
5%Arthralgia
5%Eructation
3%Lipase increased
3%Hypertension
3%Cardiac failure
3%Flatulence
2%Hyperglycaemia
1%Asthenia
1%Papillary renal cell carcinoma
1%Atrial fibrillation
1%Coronavirus infection
1%Sleep apnoea syndrome
1%Faecaloma
1%Gastroenteritis
1%Renal neoplasm
Trial Design
2 Treatment Groups
Tirzepatide
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
700 Total Participants · 2 Treatment Groups
Primary Treatment: Tirzepatide · Has Placebo Group · Phase 3
Tirzepatide
Drug
Experimental Group · 1 Intervention: Tirzepatide · Intervention Types: DrugPlacebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
Not yet FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: randomization (week 0) to study completion (estimated up to 120 weeks)
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,453 Previous Clinical Trials
3,120,025 Total Patients Enrolled
25 Trials studying Obesity
23,457 Patients Enrolled for Obesity
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,250 Previous Clinical Trials
366,853 Total Patients Enrolled
15 Trials studying Obesity
6,714 Patients Enrolled for Obesity
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have elevated levels of N-terminal pro B-type natriuretic peptide (NT-proBNP) in the blood
You have a body mass index (BMI) of 30 or more kilograms per meter squared (kg/m²).
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Texas | 20.7% |
| California | 10.3% |
| Oklahoma | 10.3% |
| Other | 58.6% |
How old are they?
| 18 - 65 | 88.5% |
| 65+ | 11.5% |
What site did they apply to?
| Westside Medical Associates of Los Angeles | 6.3% |
| St. Luke's Boise Medical Center | 12.5% |
| Midwest Heart & Vascular Specialists | 12.5% |
| Other | 68.8% |
What portion of applicants met pre-screening criteria?
| Met criteria | 55.6% |
| Did not meet criteria | 44.4% |
Why did patients apply to this trial?
- "I’m sick of being over weight"
How responsive is this trial?
Typically responds via
| Phone Call | 100.0% |
Most responsive sites:
- Aultman Hospital Research: < 48 hours
- Capital Area Research, LLC: < 48 hours
Average response time
- < 2 Days
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