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GLP-1 RA agonist
Tirzepatide for Type 2 Diabetes
Phase 4
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment 12 weeks
Follow Up 0 days
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial is testing a new medication called tirzepatide for people with type 2 diabetes. Tirzepatide helps control blood sugar by making the body produce more insulin and reducing appetite. The study aims to see if switching to this new treatment is more effective than current therapies.
Eligible Conditions
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ 12 weeks4 visits
Follow Up ~ 0 days0 visits
Screening ~ 3 weeks
Treatment ~ 12 weeks
Follow Up ~0 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Hemoglobin A1c (HbA1c)
Secondary study objectives
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values are >180 mg/dl (10 mmol/L)
Change from Baseline in Fasting Serum Glucose (FSG)
Change from Baseline in Percentage of Time per Day that Continuous Glucose Monitoring (CGM)-derived Values are >180 mg/dl (10 mmol/L)
+2 moreSide 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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will receive tirzepatide subcutaneously (SC).
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
2,671 Previous Clinical Trials
3,228,872 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
426,497 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high risk of heart disease or have had a heart attack, surgery to clear blocked blood vessels, a stroke, or hospitalization for heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Tirzepatide
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05706506 — Phase 4
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