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GLP-1 Receptor Agonist

Retatrutide Dose Level 2 for Type 2 Diabetes

Phase 3
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 Type 2 Diabetes (T2D)
Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 80
Awards & highlights

Study Summary

"This trial will compare the effectiveness and safety of retatrutide and semaglutide in people with Type 2 Diabetes who are not managing their blood sugar well with metformin alone or with

Who is the study for?
This trial is for adults with Type 2 Diabetes who aren't managing their blood sugar well using metformin alone or with an SGLT2 inhibitor. Participants should be committed to the study duration of about 26 months and up to 24 visits.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of a new diabetes medication, Retatrutide, compared to an existing one, Semaglutide. It aims to see which better controls blood sugar levels in participants over the course of the study.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or diarrhea, low blood sugar events, possible injection site reactions, and other common diabetic medication-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Type 2 Diabetes.
Select...
I have been taking at least 1500 mg of metformin daily for diabetes, with or without SGLT2i, for the last 90 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 80
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Secondary outcome measures
Change from Baseline in Body Weight
Change from Baseline in HbA1c (%)
Change from Baseline in Systolic Blood Pressure (SBP)
+9 more

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220
29%
Nasopharyngitis
9%
Constipation
9%
Nausea
8%
Upper respiratory tract inflammation
6%
Back pain
6%
Diarrhoea
5%
Decreased appetite
3%
Influenza
3%
Diabetic retinopathy
2%
Atrioventricular block second degree
2%
Abdominal discomfort
2%
Vomiting
2%
Angina pectoris
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dulaglutide 0.75 mg
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Retatrutide Dose Level 2Experimental Treatment1 Intervention
Participants will receive retatrutide administered SC.
Group II: Retatrutide Dose Level 1Experimental Treatment1 Intervention
Participants will receive retatrutide administered subcutaneously (SC).
Group III: SemaglutideActive Control1 Intervention
Participants will receive semaglutide administered SC.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,199,808 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,002 Total Patients Enrolled

Frequently Asked Questions

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

Are patients currently able to enroll in this ongoing clinical trial?

"According to the details on clinicaltrials.gov, recruitment for this investigation is presently closed. The trial was first posted on March 20, 2024 and last revised on February 8, 2024. Although this specific study is not enrolling participants currently, there are a total of 1361 other studies actively seeking eligible patients at present."

Answered by AI

At how many different sites is the administration of this trial being managed?

"The trial is being conducted at Arcturus Healthcare, PLC in Troy, Michigan; the Internal Medicine Research Division of Troy; Medication Management in Greensboro, North carolina; and RM Pharma Specialists in Mexico City. Additionally, there are 71 more locations participating in this study."

Answered by AI

Has the initial dosage of Retatrutide been officially endorsed by the FDA?

"The safety evaluation for Retatrutide Dose Level 1 yielded a rating of 3, as per our team at Power. This assessment is based on the trial being in Phase 3 and having substantial efficacy data along with numerous rounds validating its safety profile."

Answered by AI

Who else is applying?

What site did they apply to?
Neighborhood Healthcare Institute of Health
Intend Research, LLC
Juno Research
Other
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I would like to know more about the study.
PatientReceived 1 prior treatment
~833 spots leftby Dec 2026