Type 2 Diabetes Mellitus study: Elecoglipron
Official title A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin
ClinicalTrials.gov ID: NCT07662135
What this study is testing
What is Elecoglipron?
Elecoglipron is an investigational oral medicine being studied for type 2 diabetes mellitus in people with impaired kidney function.
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
- The study wants to see if elecoglipron is safe and works well compared to a placebo in people with type 2 diabetes and impaired kidney function who are on dapagliflozin and other diabetes medicines.
- Who it's for
- Adults with type 2 diabetes and chronic kidney disease who are taking dapagliflozin 10 mg and other blood‑sugar medicines.
- What's involved
- Participants will receive either elecoglipron or a placebo while continuing their current medications. They will have regular clinic visits and tests to monitor safety and effectiveness.
- Time commitment
- The study lasts several months, with multiple scheduled visits for medication administration and health checks.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 for at least 90 days prior to screening
- On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)
- On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
- SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol)
- Impaired renal function
You likely can't join if
- Type 1 Diabetes, 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 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 (New York Heart Association IV)
See the full eligibility criteria
- Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening
- On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)
- On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
- SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol)
- Impaired renal function
- 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, 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 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 (New York Heart Association 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
- Sacramento, California, United States
- Miami Lakes, Florida, United States
- Ocoee, Florida, United States
- Kansas City, Missouri, United States
- Albuquerque, New Mexico, United States
- Raleigh, North Carolina, United States
- Gaffney, South Carolina, United States
- Gifu, Japan
- Nagoya, Japan
- Toyota-Shi, Japan
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
- Zhubei, Taiwan
- Blackpool, United Kingdom
- Sandbach, United Kingdom
- Thetford, United Kingdom
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 Sacramento, California, United States; Miami Lakes, Florida, United States; Ocoee, Florida, United States; Kansas City, Missouri, United States; Albuquerque, New Mexico, United States; Raleigh, North Carolina, United States and 12 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.