Tirzepatide for Overweight

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Overweight+1 More
Tirzepatide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will look at whether tirzepatide can reduce obesity-related health problems and death in adults.

Eligible Conditions
  • Overweight
  • Obesity

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 18 Secondary · Reporting Duration: Up to 5 Years

Baseline, 156 Weeks
Change from Baseline Diastolic Blood Pressure (DBP) (mmHg)
Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)
Percent Change from Baseline in Body Weight
Baseline, 2 Years
Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score
Year 5
Kidney Failure, Chronic
Up to 5 Years
Glycosylated hemoglobin A
Time to First Occurrence Heart Failure (HF) Events
Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)
Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke)
Kidney Failure, Chronic
Time to First Occurrence of CV Death
Time to First Occurrence of Coronary Revascularization
Time to First Occurrence of Hospitalization for Unstable Angina
Time to First Occurrence of MI
Time to First Occurrence of Stroke
Time to Onset of Type 2 Diabetes (T2D)
Time to first occurrence of Hospitalization or Urgent Visit
Time to the Occurrence of All-cause Death
eGFR Slope

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%Decreased appetite
7%Dyspepsia
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%, Decreased appetite with 7%, Dyspepsia with 7%.

Trial Design

2 Treatment Groups

Tirzepatide
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

15000 Total Participants · 2 Treatment Groups

Primary Treatment: Tirzepatide · Has Placebo Group · Phase 3

Tirzepatide
Drug
Experimental Group · 1 Intervention: Tirzepatide · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~8030

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,454 Previous Clinical Trials
3,105,754 Total Patients Enrolled
18 Trials studying Overweight
7,664 Patients Enrolled for Overweight
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

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a body mass index (BMI) of 27.0 or greater.
You have coronary artery disease.
You have cerebrovascular disease.
You are 70 years of age or older, or 65 years of age or older with at least 2 risk factors at screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: November 27th, 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?
Pennsylvania38.5%
Nevada15.4%
Rhode Island15.4%
Other30.8%
How old are they?
18 - 6590.9%
65+9.1%
What site did they apply to?
Scripps Whittier Diabetes Institute14.3%
Elite Clinical Trials14.3%
Penn Medicine: University of Pennsylvania Health System14.3%
Other57.1%
What portion of applicants met pre-screening criteria?
Met criteria58.3%
Did not meet criteria41.7%
Why did patients apply to this trial?
  • "I've tried so many ways to lose weight but all have either failed or were short lived. I'm not happy with how I look and it affects every aspect of my life including social interactions. I fear that I'll never make it to retirement age (7 more years) because I'll die from some obesity related disease."
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Typically responds via
Phone Call100.0%
Most responsive sites:
  1. Chase Medical Research, LLC: < 24 hours
  2. Heritage Valley Medical Group, Inc.: < 24 hours
Average response time
  • < 1 Day