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Orforglipron for Type 2 Diabetes (ACHIEVE-5 Trial)

Verified Trial
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 HbA1c ≥7.0% [53 mmol/mol] to ≤10.5% [91 mmol/mol]
Must not have
Are you currently enrolled in another study?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 40
Awards & highlights

Summary

This trial will study the safety & effectiveness of a new drug for people with Type 2 Diabetes not well controlled with insulin & other drugs.46 weeks, up to 20 visits.

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 using insulin glargine, possibly alongside metformin or SGLT-2 inhibitors. They should have had a stable dose of insulin and body weight for the past 90 days and an HbA1c level between 7.0% to 10.5%. People with a history of pancreatitis, liver diseases other than fatty liver, severe heart failure, or recent major cardiovascular events cannot participate.
What is being tested?
The study tests the safety and effectiveness of Orforglipron in managing blood sugar in people with Type 2 Diabetes over approximately 46 weeks and up to 20 visits. Participants will be randomly assigned to receive either Orforglipron or a placebo while continuing their current diabetes medications.
What are the potential side effects?
While specific side effects are not listed here, participants may experience reactions related to Orforglipron or interactions with their existing diabetes treatments. Common drug-related side effects could include digestive issues, low blood sugar episodes, potential liver enzyme changes, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Type 2 Diabetes.
Select...
Your HbA1c levels are between 7.0% and 10.5%.
Select...
You have a body mass index (BMI) of 23 or higher.
Select...
I have been on a stable dose of insulin glargine U-100 for at least 90 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 40
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 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
Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)
Secondary outcome measures
Change from Baseline in Body Weight
Change from Baseline in Daily Insulin Glargine Dose
Change from Baseline in Fasting Serum Glucose
+11 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Orforglipron Dose 3Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group II: Orforglipron Dose 2Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group III: Orforglipron Dose 1Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo orally.

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Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,217,590 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
415,956 Total Patients Enrolled
~246 spots leftby Jun 2025
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