Orforglipron for Type 2 Diabetes

(ACHIEVE-5 Trial)

Recruiting in Palo Alto (17 mi)

+77 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

Do I have to stop taking my current medications for this trial?

No, you don't have to stop taking your current medications. The trial requires that you continue with your stable doses of insulin glargine, metformin, and/or SGLT-2 inhibitors if you are already on them.

What data supports the idea that Orforglipron for Type 2 Diabetes is an effective drug?

The available research shows that Orforglipron is effective for treating Type 2 Diabetes. In a study comparing Orforglipron to a placebo and another diabetes drug called dulaglutide, Orforglipron showed positive results. This means that people taking Orforglipron had better outcomes than those taking a placebo, and it was comparable to dulaglutide, which is already used to treat diabetes. Additionally, Orforglipron has been shown to help with weight loss in people with obesity, which is often a related issue for those with Type 2 Diabetes. ^{1 2 3 4 5}

What safety data is available for Orforglipron in treating Type 2 Diabetes?

Safety data for Orforglipron, also known as LY3502970, has been evaluated in several studies. A Phase 1b trial assessed its safety, pharmacokinetics, and pharmacodynamics in patients with Type 2 Diabetes, while a Phase 2 study compared its safety and efficacy against placebo and dulaglutide. Additionally, a Phase 1a study evaluated its safety and tolerability in healthy participants. These studies indicate that Orforglipron has been tested for safety in both diabetic and healthy individuals. ^{1 2 4 5 6}

Is the drug Orforglipron a promising treatment for Type 2 Diabetes?

Yes, Orforglipron is a promising drug for Type 2 Diabetes. It is an oral medication that helps control blood sugar levels by mimicking a natural hormone in the body. It has shown positive results in clinical trials, helping people with Type 2 Diabetes manage their condition effectively. ^{1 2 3 5 7}

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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.

Inclusion Criteria

I have been on a stable dose of insulin glargine U-100 for over 90 days.

Your HbA1c levels are between 7.0% and 10.5%.

I have been on a stable dose of insulin glargine U-100 for at least 90 days.

Exclusion Criteria

Are you currently enrolled in another study?

Treatment Details

Interventions

• Orforglipron (Other)

Trial Overview 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.

Participant Groups

Group I: Orforglipron Dose 3 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally.

Group II: Orforglipron Dose 2 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally.

Group III: Orforglipron Dose 1 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Balanced Life Health Care Solutions/SKYCRNG Lawrenceville, GA

SanRo Clinical Research Group, LLC Bryant, AR

St. Luke's Humphreys Diabetes Center: Boise Boise, ID

Cotton O'Neil Diabetes & Endocrinology Topeka, KS

More Trial Locations

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2708

Patients Recruited

3,720,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1b, multicentre, blinded, placebo-controlled, randomized, multiple-ascending-dose study in people with type 2 diabetes. Pratt, E., Ma, X., Liu, R., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Frias, JP., Hsia, S., Eyde, S., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In obesity or overweight without diabetes, orforglipron increased weight loss at 26 wk. Lau, D.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. Wharton, S., Blevins, T., Connery, L., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. Urva, S., Coskun, T., Loh, MT., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1a, blinded, placebo-controlled, randomized, single- and multiple-ascending-dose study in healthy participants. Pratt, E., Ma, X., Liu, R., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLP-1 receptor agonists: Nonglycemic clinical effects in weight loss and beyond. Ryan, D., Acosta, A.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1b, multicentre, blinded, placebo-controlled, randomized, multiple-ascending-dose study in people with type 2 diabetes. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

In obesity or overweight without diabetes, orforglipron increased weight loss at 26 wk. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. [2023]

5. England pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1a, blinded, placebo-controlled, randomized, single- and multiple-ascending-dose study in healthy participants. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

GLP-1 receptor agonists: Nonglycemic clinical effects in weight loss and beyond. [2018]