Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Elecoglipron · 10 trials · 9 indications
Time to the first occurrence of any component of this composite: * ≥ 50% sustained decline in eGFR * ESKD defined as: Sustained eGFR \< 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant \- All-cause mortality
Time to first event of the composite of: CV death HHF Urgent HF visit
Percent change from baseline to Week 52 in body weight.
Achieved at least 5% body weight loss from baseline at Week 52.
Summary statistics
Percent change from baseline to Week 72 in body weight
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.
| Arm | Type | Description |
|---|---|---|
| Elecoglipron | EXPERIMENTAL | Elecoglipron tablet once daily |
| Placebo | ACTIVE_COMPARATOR | Placebo matching Elecoglipron tablet once daily |
| Arm 1 - Dose 1 | EXPERIMENTAL | Active IMP |
| Arm 2 - Dose 2 | EXPERIMENTAL | Active IMP |
| Arm 3 - Placebo | PLACEBO_COMPARATOR | Placebo matching elecoglipron |
| Elecoglipron dose level 1 | EXPERIMENTAL | Participants will receive elecoglipron at dose level 1 administered orally once daily. |
| Elecoglipron dose level 2 | EXPERIMENTAL | Participants will receive elecoglipron at dose level 2 administered orally once daily. |
| Elecoglipron dose level 1 + dapagliflozin-matched placebo | EXPERIMENTAL | Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily. |
| Elecoglipron dose level 2 + dapagliflozin-matched placebo | EXPERIMENTAL | Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily. |
| Elecoglipron (one of the studied dose levels) + dapagliflozin | EXPERIMENTAL | Participants will receive elecoglipron at one of the study dose levels in combination with dapagliflozin, administered orally once daily. |
| Elecoglipron-matched placebo + dapagliflozin-matched placebo | PLACEBO_COMPARATOR | Participants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily. |
| Elecoglipron dose level 1 + dapagliflozin | EXPERIMENTAL | Participants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily. |
| Elecoglipron dose level 2 + dapagliflozin | EXPERIMENTAL | Participants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily. |
| Elecoglipron-matched placebo + dapagliflozin | ACTIVE_COMPARATOR | Participants will receive elecoglipron-matched placebo + dapagliflozin, administered orally once daily. |
| Semaglutide | ACTIVE_COMPARATOR | Participants will receive semaglutide dose XX mg administered orally once daily. |
| Group 1: Period 1 | EXPERIMENTAL | Participants will receive a single dose of atorvastatin on Day 1. |
| Group 1: Period 2 | EXPERIMENTAL | Participants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40. |
| Group 1: Period 3 | EXPERIMENTAL | Participants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43. |
| Group 1: Period 4 | EXPERIMENTAL | Participants will receive elecoglipron in the morning and a single dose of atorvastatin in the evening on Day 44. Participant will continue elecoglipron on Day 45. Participants will receive daily administration of different doses of elecoglipron alone from Day 46 to Day 58. |
| Group 1: Period 5 | EXPERIMENTAL | Participants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61. |
| Group 1: Period 6 | EXPERIMENTAL | Participants will receive elecoglipron in the morning and a single dose of atorvastatin in the evening on Day 62. Participant will continue elecoglipron alone from Day 63 to Day 64. |
| Group 2: Period 1 | EXPERIMENTAL | Participants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38. |
| Group 2: Period 2 | EXPERIMENTAL | Participants will receive elecoglipron in the morning along with a single dose of rosuvastatin on Day 39. Participant will continue elecoglipron alone from Day 40 to Day 44. |
| Group 2: Period 3 | EXPERIMENTAL | Participants will receive elecoglipron in the morning and a single dose of rosuvastatin in the evening on Day 45. Participant will continue on different doses of elecoglipron alone from Day 46 to Day 59. |
| Group 2: Period 4 | EXPERIMENTAL | Participants will receive elecoglipron in the morning along with a single dose of rosuvastatin on Day 60. Participant will continue elecoglipron alone from Day 61 to Day 65. |
| Group 2: Period 5 | EXPERIMENTAL | Participants will receive elecoglipron in the morning and a single dose of rosuvastatin in the evening on Day 66. Participant will continue on elecoglipron alone from Day 67 to Day 69 and from Day 73 to Day 86. |
| Group 2: Period 6 | EXPERIMENTAL | Participants will receive elecoglipron and a single dose of rosuvastatin in the morning on Day 87. Participants will continue elecoglipron from Day 87 to Day 91. |
| Group 2: Period 7 | EXPERIMENTAL | Participants will receive a single dose of rosuvastatin in the morning on Day 106. |
| Name | Type | Description |
|---|---|---|
| Elecoglipron | DRUG | Elicoglipron tablet |
| Placebo | DRUG | Placebo tablet |
| Dapagliflozin | DRUG | Dapagliflozin administered orally once daily. |
| Elecoglipron-matched placebo | DRUG | A placebo matching elecoglipron, administered orally once daily. |
| Dapagliflozin-matched placebo | DRUG | A placebo matching dapagliflozin, administered orally once daily. |
| Semaglutide | DRUG | Semaglutide is administered orally once daily. |
| Atorvastatin | DRUG | Atorvastatin will be administered as oral tablet. |
| Rosuvastatin | DRUG | Rosuvastatin will be administered as oral tablet. |
Inclusion Criteria: * Adults with confirmed CKD; UACR ≥30 mg/g and eGFR ≥20 mL/min/1.73 m² within specified ranges. * On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening. Exclusion Criteria: * BMI \<23 kg/m² at screening * History...
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Elecoglipron is an investigational small molecule being studied for obesity, heart failure with preserved ejection fraction (HFpEF), type 2 diabetes mellitus, weight management, chronic kidney disease, and in healthy participants. It is being developed by AstraZeneca PLC (AZN) and is currently in Phase 3 clinical trials.
Elecoglipron is a small molecule therapeutic being developed by AstraZeneca. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for its effects on metabolic and cardiovascular conditions, including type 2 diabetes and heart failure.
Elecoglipron is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 3 clinical development for multiple indications, including type 2 diabetes mellitus and heart failure.
Elecoglipron is currently in Phase 3 clinical trials. It is an investigational drug and has not yet been approved by regulatory authorities. AstraZeneca is conducting multiple Phase 3 studies to evaluate its efficacy and safety in conditions such as type 2 diabetes and heart failure.
Elecoglipron is being studied in several Phase 3 trials, including NCT07662044, NCT07662135, NCT07662213, and NCT07761117. These trials are recruiting or about to recruit participants with type 2 diabetes, chronic kidney disease, and heart failure with preserved or mildly reduced ejection fraction.
No, Elecoglipron is a distinct investigational drug. In clinical trials, it is being studied alone or in combination with dapagliflozin, and compared against semaglutide, which are already approved medicines for type 2 diabetes. Elecoglipron is not the same as either of these drugs.