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GLP-1 Receptor Agonist

Retatrutide vs Semaglutide 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
Must not have
Have a prior or planned surgical treatment for obesity
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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
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I have Type 2 Diabetes.
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I have been taking at least 1500 mg of metformin daily for diabetes, with or without SGLT2i, for the last 90 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had or am planning to have surgery for weight loss.
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I have been cancer-free or in remission for less than 5 years.
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I or my family have a history of medullary thyroid cancer or MEN syndrome Type 2.
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My kidney function is lower than normal, as measured by eGFR.
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I have severe heart failure.
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I have not had a heart attack, stroke, or been hospitalized for heart failure in the last 3 months.
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I have had pancreatitis before.
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I have used weight loss medications or remedies in the last 90 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220
26%
Nasopharyngitis
9%
Constipation
7%
Influenza
5%
Diabetic retinopathy
5%
Nausea
4%
Gastrooesophageal reflux disease
3%
Back pain
3%
Upper respiratory tract inflammation
2%
Abdominal discomfort
2%
Vomiting
2%
Diarrhoea
1%
Cardiac ablation
1%
Herpes zoster
1%
Ischaemic cerebral infarction
1%
Acute myocardial infarction
1%
Appendicitis
1%
Large intestine polyp
1%
Peritonitis
1%
Sudden hearing loss
1%
Rectal adenocarcinoma
1%
Spinal operation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg
Dulaglutide 0.75 mg

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.

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
2,671 Previous Clinical Trials
3,227,772 Total Patients Enrolled
11 Trials studying Diabetes
15,619 Patients Enrolled for Diabetes
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
425,397 Total Patients Enrolled
3 Trials studying Diabetes
4,328 Patients Enrolled for Diabetes
~833 spots leftby Dec 2026
Unbiased ResultsWe believe in providing patients with all the options.
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