Tirzepatide for Obesity

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Obesity+2 More
Tirzepatide - Drug
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

2 of 3
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

3 of 3
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
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT04039503) in the 5 mg Tirzepatide ARM group. Side effects include: Nasopharyngitis with 16%, Nausea with 13%, Diarrhoea with 12%, Dyspepsia with 7%, Decreased appetite with 7%.

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: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
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 preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

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?
Texas20.7%
California10.3%
Oklahoma10.3%
Other58.6%
How old are they?
18 - 6588.5%
65+11.5%
What site did they apply to?
Westside Medical Associates of Los Angeles6.3%
St. Luke's Boise Medical Center12.5%
Midwest Heart & Vascular Specialists12.5%
Other68.8%
What portion of applicants met pre-screening criteria?
Met criteria55.6%
Did not meet criteria44.4%
Why did patients apply to this trial?
  • "I’m sick of being over weight"

How responsive is this trial?

Typically responds via
Phone Call100.0%
Most responsive sites:
  1. Aultman Hospital Research: < 48 hours
  2. Capital Area Research, LLC: < 48 hours
Average response time
  • < 2 Days