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GLP-1 Receptor Agonist
Tirzepatide for Type 2 Diabetes and Obesity
Verified Trial
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
Are you currently taking Metformin only to manage your diabetes?
Be older than 18 years old
Must not have
Have you ever had surgery for obesity, or do you plan to undergo surgery shortly?
Do you have a recent history of myocardial infarction, stroke, unstable angina, congestive heart failure, or coronary artery revascularization?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 44
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.
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.
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 belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 44
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 44
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Side effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Vomiting
11%
Gastroenteritis
9%
Flatulence
9%
Abortion induced
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Vaginal infection
3%
Dizziness
1%
Hand fracture
1%
Supraventricular tachycardia
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Tirzepatide
15 mg Tirzepatide
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
~7520
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,034 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,491 Total Patients Enrolled