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Researchers Test New Oral Drug for Type 2 Diabetes and Obesity

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Multiple clinical trials are recruiting participants to see how well the investigational drug orforglipron can improve blood glucose levels and reduce body weight.  

A potential new oral drug, orforglipron, is currently being studied to see its impact on glucose control and weight loss in people with obesity, type 2 diabetes, or both conditions. 

Orforglipron is a once-daily oral GLP-1 receptor agonist being developed by Eli Lilly. The latest data for orforglipron showed A1C reductions of up to 2.1% and weight loss of up to 22 pounds over 26 weeks, suggesting it could be a viable option as a weight loss medication.

Researchers highlighted that orforglipron, a medication taken by mouth, has the potential to reduce the need for injections in people with type 2 diabetes. The only other oral GLP-1 currently available is Rybelsus (semaglutide); another investigational drug yet to be approved also being studied is danuglipron. There are more than 10 clinical trials currently underway testing orforglipron in people with diabetes or obesity – here are the ones currently recruiting.

Orforglipron for obesity 

Clinical Trials Identifier: NCT06440980

Trial Name: A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

Diabetes Type: Not being tested for diabetes, only in healthy adults with overweight or obesity

Trial Sponsor: Lilly

This study will be conducted in two parts and is expected to last approximately 47 weeks (part A 25 weeks, part B 22 weeks). This is a phase 1 clinical trial, meaning an early-stage study. Researchers plan to enroll 508 participants in seven locations across the U.S. The study will assess the safety and tolerability of orforglipron, as well as how long it takes the drug to exit the body in healthy people with overweight or obesity.  

You may be eligible to participate if you:  

  • Are between ages 18 and 65
  • Are deemed healthy as determined by a physical exam and medical history
  • Have a stable body weight for up to one month prior to screening and a body mass index (BMI) of 27 

You are not eligible to participate if you:

  • Have an A1C of 6.5% or higher
  • Have a history of heart, respiratory, kidney, gastrointestinal, endocrine (including diabetes), or neurological disorders. This includes a history of mental health conditions.
  • Have undergone bariatric surgery 

See a full list of inclusion/exclusion criteria and study site locations here.

ACHIEVE-2

Clinical Trials Identifier: NCT06192108

Trial Name: A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-2)

Diabetes Type: Adults with type 2 diabetes

Trial Sponsor: Lilly

This study is expected to last approximately 46 weeks. Researchers plan to enroll 888 participants in roughly 76 locations across the globe including China, Poland, Mexico, and the U.S. ACHIEVE-2 will be assessing the safety and efficacy of orforglipron for blood sugar management compared to dapagliflozin (Farxiga), an oral medication used to treat type 2 diabetes, heart failure, and chronic kidney disease.

You may be eligible to participate if you:  

  • Are 18 years or older and have type 2 diabetes and an A1C of 7-10%
  • Have a BMI of 23 or higher
  • Have been on a diabetes treatment plan that includes 1,500 mg or more of metformin per day prior to screening 

You are not eligible to participate if you:

  • Have type 1 diabetes
  • Are receiving treatment for diabetic retinopathy or diabetic macular edema
  • Have a history of pancreatitis
  • Are being treated with any type of blood glucose medication (besides metformin) within 90 days prior to screening

See a full list of inclusion/exclusion criteria and study site locations here.

ACHIEVE-5

Clinical Trials Identifier: NCT06109311

Trial Name: A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/​or SGLT-2 Inhibitor (ACHIEVE-5)

Diabetes Type: Adults with type 2 diabetes

Trial Sponsor: Lilly

ACHIEVE-5 is expected to last approximately 46 weeks. Researchers plan to enroll 520 participants in countries including Brazil, China, Romania, Japan, and the U.S. This study will also be testing the safety of orforglipron in people with type 2 diabetes taking insulin glargine (long-acting) with or without metformin and/or an SGLT-2 inhibitor medication. 

You may be eligible to participate if you:  

  • Have type 2 diabetes and an A1C of 7-10%
  • Have been taking (for 90 days or more) insulin glargine with metformin, an SGLT-2 inhibitor, or both
  • Have a BMI of 23 or higher

You are not eligible to participate if you:

  • Have or have had any cardiovascular-related issues or conditions such as heart attack, stroke, or heart failure
  • Have a history of liver disease or pancreatitis

See a full list of inclusion/exclusion criteria and study site locations here.

Are you interested? 

For more information on any of these studies, contact [email protected] or call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559. 

Learn more about research for GLP-1 receptor agonists in diabetes: