Type 2 Diabetes Mellitus study: Elecoglipron vs Semaglutide
Official title A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT07662213
What this study is testing
What is Elecoglipron?
Elecoglipron is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for type 2 diabetes mellitus.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether elecoglipron works as well as semaglutide. It also checks how safe both medicines are.
- Who it's for
- You may be able to join if you have type 2 diabetes and high heart risk.
- What's involved
- You would take a daily pill. You would also get regular check-ups and blood tests.
- Time commitment
- The study lasts for a set time with regular visits to the clinic.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
- T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s)
- HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
- Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic...
- Body mass index (BMI) of ≥ 23 kg/m2 at screening
You likely can't join if
- Type 1 Diabetes Mellitus (T1DM), secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
- Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
- Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor...
- Clinically significant condition affecting the upper Gastrointestinal (GI) tract or chronic use of any medication that affects gastric motility or...
- History of acute or chronic pancreatitis
- Severe congestive heart failure (NYHA IV)
See the full eligibility criteria
- Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
- T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s)
- HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
- Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors
- Body mass index (BMI) of ≥ 23 kg/m2 at screening
- Stable body weight (self-reported or documented) for 90 days prior to screening
- Type 1 Diabetes Mellitus (T1DM), secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
- Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
- Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- Clinically significant condition affecting the upper Gastrointestinal (GI) tract or chronic use of any medication that affects gastric motility or gastric emptying
- History of acute or chronic pancreatitis
- Severe congestive heart failure (NYHA IV)
- History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Encinitas, California, United States
- Pomona, California, United States
- Sacramento, California, United States
- Lake City, Florida, United States
- Leesburg, Florida, United States
- Ames, Iowa, United States
- Rockville, Maryland, United States
- Henderson, Nevada, United States
- Morehead City, North Carolina, United States
- Wilmington, North Carolina, United States
- Houston, Texas, United States
- Sugar Land, Texas, United States
- Buenos Aires, Argentina
- Caba, Argentina
- Ciudad de Buenos Aires, Argentina
- Rosario, Argentina
- San Vicente, Argentina
- Botany, Australia
- East Toowoomba, Australia
+ 71 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Encinitas, California, United States; Pomona, California, United States; Sacramento, California, United States; Lake City, Florida, United States; Leesburg, Florida, United States and 85 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.