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GLP-1 Receptor Agonist

Tirzepatide High Dose 1 for Obesity

Phase 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have been diagnosed with Type 2 Diabetes (T2D)
Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 24), week 80
Awards & highlights

Study Summary

This trial aims to see how safe and effective different doses of tirzepatide are for people with Type 2 diabetes and obesity who are already on metformin. The study will go on

Who is the study for?
This trial is for adults with Type 2 diabetes and obesity, specifically those with a BMI of 35 or higher who have maintained a stable weight and been on metformin treatment for at least 90 days. Participants should not have had significant weight changes recently.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of different doses of an experimental drug called Tirzepatide in people taking metformin for Type 2 diabetes and obesity over approximately 89 weeks. Some participants will receive Tirzepatide, while others will get a placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, investigational drugs like Tirzepatide can potentially cause reactions ranging from mild to severe, including but not limited to nausea, headaches, allergic reactions or other unforeseen complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Type 2 Diabetes.
Select...
I have been taking at least 1500 mg of metformin daily for the last 90 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 24), week 80
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 24), week 80 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in Body Weight
Secondary outcome measures
Absolute Change from Baseline in Body Weight
Change from Baseline in BMI
Change from Baseline in Body Mass Index (BMI)
+5 more

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032
40%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Tirzepatide High Dose 2Experimental Treatment1 Intervention
Participants will receive tirzepatide SC.
Group II: Tirzepatide High Dose 1Experimental Treatment1 Intervention
Participants will receive tirzepatide subcutaneously (SC).
Group III: TirzepatideActive Control1 Intervention
Participants will receive tirzepatide SC.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~5780

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,216,249 Total Patients Enrolled
55 Trials studying Obesity
50,869 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,395 Total Patients Enrolled
38 Trials studying Obesity
30,588 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being enrolled in this clinical trial?

"Indeed, information on clinicaltrials.gov confirms that this particular clinical trial is presently in the recruitment phase. The study was first listed on September 21st, 2023 and underwent its most recent update on February 28th, 2024. Recruitment aims to enroll a total of 350 participants across a network of 70 sites."

Answered by AI

Does this study allow individuals who are older than 75 years to participate?

"Individuals interested in enrolling in this research study must be at least 18 years old and no older than 75."

Answered by AI

Are prospective patients still eligible to participate in this ongoing medical study?

"Indeed, the details on clinicaltrials.gov imply that this investigation is actively enrolling subjects. The trial was initially shared on 9/21/2023 and most recently revised on 2/28/2024. Specifically, the research aims to recruit 350 individuals from a network of 70 sites."

Answered by AI

In how many distinct settings is this research study being conducted?

"The clinical trial is conducted at Clalit Health Services - Sakhnin Community Clinic in Sakhnin, HaTsafon, Cheadle Community Hospital in Cheadle, Staffordshire, and Bnai Zion Medical Center in Haifa, Oregon among 70 additional sites."

Answered by AI

What is the safety profile of Tirzepatide High Dose 2 in individuals?

"Our research team at Power has evaluated the safety of Tirzepatide High Dose 2 to be a 2 on our scale. This rating is attributed to it being part of a Phase 2 trial, indicating existing data supporting its safety but not yet for efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Southern Endocrinology Associates
Other
Northwest Clinical Research Center
Medical Advancement Centers of Arizona
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Four diabetes drugs later, still have A1c of 7.1.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity
2023. "A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06037252.
All > New Orleans > Vancouver
~163 spots leftby Dec 2024
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