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Glucagon-like peptide-1 receptor agonist

Tirzepatide for Type 2 Diabetes (SURPASS-EARLY Trial)

Verified Trial
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
Have you been diagnosed with type II diabetes?
Are you currently being treated with only metformin, or are you willing to start?
Must not have
Have you been diagnosed with or treated for cancer in the past 5 years, excluding skin cancer?
Are you taking insulin or any other anti-diabetic medications?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 208
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will compare the effectiveness of tirzepatide versus other diabetes treatments when started early.

Who is the study for?
Adults with type 2 diabetes who have been diagnosed within the last 4 years, currently treated only with metformin, and have HbA1c levels between ≥7% to ≤9.5%. They must not be on insulin or other anti-diabetic meds, have a history of certain thyroid cancers or syndromes (MTC/MEN2), pancreatitis, recent cancer treatments (except skin cancer), weight loss surgery, or severe diabetic eye disease.
What is being tested?
The trial is testing Tirzepatide's effectiveness and safety against standard care in adults with early-stage type 2 diabetes. Participants will either receive Tirzepatide or intensified conventional antihyperglycemic medication to compare outcomes.
What are the potential side effects?
Tirzepatide may cause side effects such as nausea, vomiting, diarrhea, decreased appetite leading to weight loss; there could also be potential risks for thyroid tumors and inflammation of the pancreas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with type II diabetes.
Select...
I am currently taking metformin or willing to start it.
Select...
I was diagnosed with type 2 diabetes in the last 4 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had cancer, except for skin cancer, in the last 5 years.
Select...
I am taking insulin or other medications for diabetes.
Select...
I have had weight loss surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 208
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 208 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)]
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)]
+4 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%
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
Group II: Intensified Conventional Care DoseActive Control1 Intervention
Participants will receive an antihyperglycemic medication
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
3,465,604 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,061 Total Patients Enrolled

Media Library

Tirzepatide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05433584 — Phase 4
Type 2 Diabetes Research Study Groups: Tirzepatide, Intensified Conventional Care Dose
Type 2 Diabetes Clinical Trial 2023: Tirzepatide Highlights & Side Effects. Trial Name: NCT05433584 — Phase 4
Tirzepatide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05433584 — Phase 4
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05433584 — Phase 4
~185 spots leftby Oct 2025
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