Five 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.
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.
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.
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:
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.
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.
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:
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.
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 »
New data from a large clinical trial of adults who had experienced a recent heart attack showed that the SGLT-2 inhibitor Jardiance reduced the risk of...
Explore GLP-1 agonists for weight loss in type 1 diabetes with caution. Understand potential risks like hypoglycemia and DKA, while balancing benefits for heart and...
Due to increased demand, diabetes and weight loss medications like Mounjaro, Ozempic, Wegovy, and Zepbound continue to be in short supply for the foreseeable future....