Tirzepatide for Obesity

SKY Clinical Research Network Group - Hall, Fayette, MS
Obesity+2 More ConditionsTirzepatide - Drug
All Sexes
What conditions do you have?

Study Summary

This trial will assess the effectiveness & safety of a new drug for adults with obesity & related conditions, lasting 78 weeks.

Eligible Conditions
  • Obesity

Treatment Effectiveness

Phase-Based Effectiveness

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

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Week 72

Baseline, Week 72
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Waist Circumference in Centimeter (cm)
Change from Baseline in Weight Circumference in Centimeter (cm)
Percent Change from Baseline in Body Weight
Week 72
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Percentage of Participants Who Achieve ≥25% Body Weight Reduction
Percentage of Participants Who Achieve ≥30% Body Weight Reduction

Trial Safety

Phase-Based Safety

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

Side Effects for

5 mg Tirzepatide
7%Decreased appetite
5%Back pain
3%Lipase increased
3%Cardiac failure
1%Papillary renal cell carcinoma
1%Sleep apnoea syndrome
1%Atrial fibrillation
1%Coronavirus infection
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%, Vomiting with 7%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Semaglutide 2.4 Milligram (mg)
1 of 2
1 of 2

Active Control

Experimental Treatment

700 Total Participants · 2 Treatment Groups

Primary Treatment: Tirzepatide · No Placebo Group · Phase 3

Experimental Group · 1 Intervention: Tirzepatide · Intervention Types: Drug
Semaglutide 2.4 Milligram (mg)
ActiveComparator Group · 1 Intervention: Semaglutide 2.4 mg · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 72

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,497 Previous Clinical Trials
3,152,819 Total Patients Enrolled
31 Trials studying Obesity
31,318 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
1,278 Previous Clinical Trials
379,269 Total Patients Enrolled
21 Trials studying Obesity
14,573 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You possess a BMI of 30 kg/m² or greater, or 27 kg/m² and have been diagnosed with one or more weight related complications such as hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease.
You have attempted to lose body weight unsuccessfully in the past.

Who else is applying?

What state do they live in?
What site did they apply to?
L-MARC Research Center10.5%
Tribe Clinical Research, LLC10.5%
Velocity Clinical Research, Dallas10.5%
What portion of applicants met pre-screening criteria?
Met criteria72.0%
Did not meet criteria28.0%
Why did patients apply to this trial?
  • "I need help losing weight"
  • "Again, I've been on every diet possible,"
  • "Hoping this trial will help. I have had several unsuccessful attempts."
  • "I've tried several weight loss drugs and I wasn't successful in losing weight."
  • "I have tried everything such as diets, exercise, stomach stapling etc. I need to get in this study"
How many prior treatments have patients received?
What questions have other patients asked about this trial?
  • "How long does screening visit take?"
  • "How often would one have to come to the site for visits?"
  • "Which medication and how much is the compensation for the study?"
  • "How long do screening visits take? How often do we meet for in person visits?"
  • "How long do you anticipate the trial taking? Am I required to physically come in to your facility on a set schedule or a specific number of visits per month? Is any of this study able to be done without the need to visit in person?"

Frequently Asked Questions

Has Tirzepatide been ratified by the FDA?

"The safety of tirzepatide was rated a 3 on our scale due to the multiple rounds of evidence confirming its efficacy and prior clinical data backing up its security." - Anonymous Online Contributor

Unverified Answer

How many healthcare facilities are conducting this investigation?

"This clinical trial is hosting recruitment at 61 different locations, including Pelham, Santa Ana and Spring Valley. To reduce the burden of travel for study participants it is recommended to select the closest site possible." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies still available for prospective participants in this trial?

"The data hosted on clinicaltrials.gov reveals that this study is not currently seeking participants, which was first unveiled on April 28th 2023 and has since been edited as recently as April 10th of the same year. Nonetheless, there are still over a thousand trials actively enrolling patients at present." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.