Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALN-4324 · 2 trials · 2 indications
M-value is measured as the glucose infusion rate at steady state
| Arm | Type | Description |
|---|---|---|
| ALN-4324 | EXPERIMENTAL | Participants will be administered a single dose of ALN-4324. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered a single dose of placebo. |
| Part A: ALN-4324 | EXPERIMENTAL | Participants will be administered a single dose of ALN-4324. |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants will be administered a single dose of placebo. |
| Part B: ALN-4324 | EXPERIMENTAL | Participants will be administered multiple doses of ALN-4324 |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants will be administered multiple doses of placebo |
| Name | Type | Description |
|---|---|---|
| ALN-4324 | DRUG | ALN-4324 will be administered subcutaneously (SC). |
| Placebo | DRUG | Placebo will be administered SC. |
Inclusion Criteria: * Is an adult patient with a confirmed diagnosis of T2DM * Has a body mass index (BMI) of ≥23 kg/m\^2 to ≤39.9 kg/m\^2 * Has a hemoglobin A1c (HbA1c) ≥6.5% to \<10.5% * Is on a stable dose of metformin, sodium-glucose cotransporter 2 inhibitor (SGLT2i), or dipeptidyl peptidase-4...
ALN-4324 is an investigational small molecule drug being developed by Alnylam Pharmaceuticals, Inc. for the treatment of Type 2 Diabetes Mellitus (T2DM). It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied for its effects on insulin sensitivity and in overweight to obese patients with T2DM.
ALN-4324 is being studied for use in Type 2 Diabetes Mellitus (T2DM). One Phase 2 trial is evaluating its effect on insulin sensitivity in adults with T2DM, while a Phase 1 trial includes overweight to obese healthy volunteers and overweight to obese patients with T2DM. It is investigational and not approved for any use.
ALN-4324 is being developed by Alnylam Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ALNY. Alnylam is the sponsor of the clinical trials evaluating ALN-4324 in Type 2 Diabetes Mellitus and in overweight to obese populations.
ALN-4324 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two trials are listed: a Phase 2 study evaluating insulin sensitivity in adults with Type 2 Diabetes Mellitus and a Phase 1 study in overweight to obese healthy volunteers and patients with T2DM.
ALN-4324 is being evaluated in two registered clinical trials. NCT07465224 is a recruiting Phase 2 study of ALN-4324 on insulin sensitivity in adults with Type 2 Diabetes Mellitus in the United States, with 24 participants. NCT06845202 is an active, not recruiting Phase 1 study in overweight to obese healthy volunteers and patients with T2DM across six countries, with 105 participants.
No, ALN-4324 is not FDA approved. It is an investigational small molecule in Phase 2 clinical development for Type 2 Diabetes Mellitus. Both of its registered trials, the Phase 2 insulin sensitivity study NCT07465224 and the Phase 1 study NCT06845202, are ongoing, with no completed trials reported.