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GLP-1 Receptor Agonist

Retatrutide Dose Level 1 for Diabetes

Phase 3

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 Varies

Follow Up week 40

Awards & highlights

Study Summary

This trial aims to see if retatrutide is better than a placebo for treating Type 2 Diabetes in patients with poor blood sugar control. It will last around 11 months and participants may need

Who is the study for?

This trial is for adults with Type 2 Diabetes who haven't been able to control their blood sugar levels through diet and exercise alone. Participants should be committed to the study duration of about 11 months and up to 11 visits.Check my eligibility

What is being tested?

The trial is testing the effectiveness and safety of a new medication called Retatrutide compared to a placebo, which has no active ingredients, in managing blood sugar levels in people with Type 2 Diabetes.See study design

What are the potential side effects?

Potential side effects of Retatrutide are not specified here but may include reactions similar to other diabetes medications such as low blood sugar, nausea, digestive issues, or allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 40

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 40

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40 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 Fasting Serum Glucose

Change from Baseline in Systolic Blood Pressure (SBP)

+10 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Retatrutide Dose Level 3Experimental Treatment1 Intervention

Participants will receive retatrutide administered SC.

Group II: Retatrutide Dose Level 2Experimental Treatment1 Intervention

Participants will receive retatrutide administered SC.

Group III: Retatrutide Dose Level 1Experimental Treatment1 Intervention

Participants will receive retatrutide administered subcutaneously (SC).

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo administered SC.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,621 Previous Clinical Trials

3,216,142 Total Patients Enrolled

11 Trials studying Diabetes

15,619 Patients Enrolled for Diabetes

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,265 Total Patients Enrolled

3 Trials studying Diabetes

4,328 Patients Enrolled for Diabetes

Frequently Asked Questions

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

Are there any available positions for participants in this research study?

"As per clinicaltrials.gov, this current research endeavor is not presently seeking participants. The trial's initial posting occurred on May 1st, 2024, with the most recent update documented on April 4th of the same year. Though inactive for recruitment at present, there are a plethora of alternative studies - totaling to be 1401 in number - that are actively accepting volunteers."

Answered by AI

Has the FDA given its approval for Retatrutide Dose Level 3?

"The safety rating for Retatrutide Dose Level 3 has been assigned a score of 3 by our experts at Power, reflecting the robust support from both efficacy and extensive safety data in this Phase 3 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

2024. "Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06354660.