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Researchers Test New Oral Drug for Type 2 Diabetes and Obesity

Published: 11/13/23 2:09 pm
By April Hopcroft
A doctor conducts clinical trial researchFive 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. 
 
Researchers highlighted that orforglipron, a medication taken by mouth, has the potential to reduce the need for injections in people with type 2 diabetes. Other oral GLP-1s include Rybelsus (semaglutide) as well as another investigational drug yet to be approved, danuglipron
 

ACHIEVE 1

Clinical Trials Identifier: NCT05971940
 
Trial Name: A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (ACHIEVE-1)
 
Diabetes Type: Adults with type 2 diabetes
 
Trial Sponsor: Lilly
 
ACHIEVE 1 is expected to last about 54 weeks and may include up to 13 site visits. Researchers plan to enroll 520 participants worldwide. The study will measure changes in A1C, body weight, and other cardiometabolic health measures like blood pressure, cholesterol, and triglycerides
 
You may be eligible to participate if you:  People with diabetes exercising
  • Have type 2 diabetes and are 18 years or older

  • Have an A1C 7.0-9.5% 

  • Have a body mass index (BMI) of at least 23 

  • Have never used insulin therapy or any oral or injectable diabetes medications 90 days prior to the trial

  • Have been at a stable weight (±5%) for at least 90 days prior to the trial

You are not eligible to participate if you:
See a full list of inclusion and exclusion criteria for ACHIEVE 1 and a list of study site locations here
 

ACHIEVE 3

Clinical Trials Identifier: NCT06045221 
 
Trial Name: A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin (ACHIEVE-3)
 
Diabetes Type: Adults with type 2 diabetes
 
Trial Sponsor: Lilly
 
ACHIEVE 3 is expected to last about 61 weeks and may include up to 13 site visits. Researchers plan to enroll 1,576 participants worldwide. The study will measure changes in A1C, body weight, and other cardiometabolic health measures (blood pressure, cholesterol, and triglycerides). 
 
You may be eligible to participate if you:  
  • Have type 2 diabetes and are 18 years or older

  • Have an A1C 7.0-10.5%

  • Have been on a stable dose of metformin (1500 mg more per day) or during the 90 days prior to the trial

  • Have been at a stable weight (±5%) for at least 90 days prior to the trial

You are not eligible to participate if you:
  • Have type 1 diabetes

  • Have a history of ketoacidosis or hyperosmolar state, heart failure, acute or chronic hepatitis, or are being treated for diabetic retinopathy or macular edema

See a full list of inclusion and exclusion criteria for ACHIEVE 3 and a list of study site locations here
 

ACHIEVE 4

Clinical Trials Identifier: NCT05803421
 
Trial Name: A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk (ACHIEVE-4)
 
Diabetes Type: Adults with type 2 diabetes
 
Trial Sponsor: Lilly
 
ACHIEVE 4 is expected to last about two years and may include up to 27 site visits. Researchers plan to enroll 2,620 participants worldwide. The study will measure cardiovascular events (heart attack, stroke, hospitalization for unstable angina, or cardiovascular death), as well as changes in A1C and body weight. 
 
You may be eligible to participate if you:  
  • Have type 2 diabetes and are 18 years or older

  • Have an A1C of 7.0-10.5% (if you are not taking a sulfonylurea) or an A1C 7.5-10.5% if you are on a sulfonylurea

  • Have a BMI of at least 25

  • Have been on a stable dose of 1-3 oral diabetes drugs (metformin, SGLT-2 inhibitors, or sulfonylureas) for at least 90 days prior to the trial 

  • Have an increased risk for heart-related complications due to: A person is tested for high blood pressure

  • Have been at a stable weight (±5%) for at least 90 days prior to the trial

You are not eligible to participate if you:
  • Have type 1 diabetes

  • Have a history of pancreatitis, a gastric emptying abnormality, acute or chronic hepatitis, or are being treated for diabetic retinopathy or macular edema 

  • Have had a heart attack, stroke, or hospitalization for heart failure within 60 days prior to the trial 

See a full list of inclusion and exclusion criteria for ACHIEVE 4 and a list of study site locations here
 

ATTAIN 1 

Clinical Trials Identifier: NCT05869903
 
Trial Name: A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)
 
Diabetes Type: Adults who have overweight or obesity but not diabetes
 
Trial Sponsor: Lilly
 
The study will last about 3.5 years and may include up to 39 site visits. Researchers plan to enroll 3,000 participants worldwide. The trial will measure changes in body weight, A1C, and other cardiometabolic health measures, such as waist circumference, blood pressure, cholesterol, and triglycerides. 
 
You may be eligible to participate if you:  
  • Are 18 years or older

  • Have a BMI of:

    • At least 30 or 

    • At least 27 with one or more of the following weight-related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease

  • Have at least one unsuccessful attempt to lose weight through dietary changes

You are not eligible to participate if you:
  • Have type 1, type 2, or any other kind of diabetes

  • Have a history of ketoacidosis, hyperosmolar state, or pancreatitis

  • Have a self-reported change in body weight of more than 11 pounds within 90 days of the trial

  • Have family (first-degree relative) or personal history of medullary thyroid cancer or multiple endocrine neoplasia 2 (MEN2) syndrome

See a full list of inclusion and exclusion criteria for ACHIEVE 1 and a list of study site locations here.
 

ATTAIN 2 

Clinical Trials Identifier: NCT05872620
 
Trial Name: A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)
 
Diabetes Type: Adults with type 2 diabetes and overweight or obesity
 
Trial Sponsor: Lilly
 
ATTAIN 2 is expected to last approximately 77 weeks and may include up to 22 site visits. Researchers plan to enroll 1,500 participants worldwide. The study will measure changes in weight, A1C, and other cardiometabolic health measures (blood pressure, cholesterol, and triglycerides). 
 
You may be eligible to participate if you:  
  • Have a BMI of at least 27 and are 18 years or older

  • Have at least one unsuccessful attempt to lose weight through dietary changes

  • Have type 2 diabetes with an A1C 7.0-10.0% and are on stable treatment for at least 90 days prior to the trial, consisting of: 

  • Either diet and exercise alone, or

  • Up to three oral diabetes medications, excluding DPP-4 inhibitors and GLP-1 receptor agonists

You are not eligible to participate if you:A person with obesity eating a salad
  • Have any type of diabetes except type 2 diabetes 

  • Have a history of ketoacidosis or hyperosmolar state, pancreatitis, or are being treated for diabetic retinopathy or macular edema

  • Have family (first-degree relative) or personal history of medullary thyroid cancer or MEN2 syndrome

See a full list of inclusion and exclusion criteria for ATTAIN 2 and a list of study site locations here.
 

Are you interested? 

Contact ClinicalTrials.gov@lilly.com 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:  
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About the authors

April Hopcroft joined diaTribe in 2023 as a Staff Writer after co-leading the Diabetes Therapy team at Close Concerns. She graduated from Smith College in 2021, where she majored in... Read the full bio »