Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
niacin laropiprant · 7 trials · 8 indications
Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7\*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, \>0 to 0.5, \>0.5 to 1, \>1 to 2, \>2 to 3, and \>3 days per week.
Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days. The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable. Period 3 was not analyzed as bleeding time was not an objective for this part of the study.
Measure of rate of absorption of ER niacin
Measure of extent of absorption of ER niacin
Measure of extent of absorption of laropiprant
Measure of rate of absorption of laropiprant
| Arm | Type | Description |
|---|---|---|
| ERN/LRPT | EXPERIMENTAL | One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks |
| ERN/LRPT then ERN | EXPERIMENTAL | One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks. |
| 1 | OTHER | One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose. |
| 2 | ACTIVE_COMPARATOR | Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks. |
| Period 1 | EXPERIMENTAL | In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). |
| Period 2 | EXPERIMENTAL | In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). |
| Period 3 | EXPERIMENTAL | - |
| A | ACTIVE_COMPARATOR | MK0524A Source 1 (Phase III manufacturing site) |
| B | ACTIVE_COMPARATOR | MK0524A Source 2 (commercial manufacturing site) |
| Name | Type | Description |
|---|---|---|
| ER niacin (+) laropiprant (ERN/LRPT) | DRUG | One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks |
| Extended-release niacin (ERN) | DRUG | Two 1g tablets ERN (2g total) once daily for 12 weeks. |
| Placebo to ERN/LRPT | DRUG | One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks |
| Comparator: simvastatin | DRUG | simvastatin (20mg to 40mg) for 12 weeks. |
| niacin (+) laropiprant | DRUG | One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose. |
| Comparator: atorvastatin calcium | DRUG | atorvastatin calcium (20mg to 40mg) for 12 weeks. |
| niacin | DRUG | Duration of Treatment: 18 Weeks |
| ER-niacin | DRUG | Duration of Treatment - 24 weeks |
| Comparator: placebo (unspecified) | DRUG | - |
| Comparator: aspirin | DRUG | 81 mg oral tablet once daily for 7 days |
| Comparator: clopidogrel | DRUG | 75 mg oral tablet once daily for 7 days |
| Comparator: laropiprant | DRUG | 40 mg oral tablet once daily for 7 days |
| Comparator: placebo | DRUG | placebo oral tablet once daily for 7 days |
| niacin (+) laropiprant (Source 1) | DRUG | Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods. |
| Comparator: niacin (+) laropiprant (Source 2) | DRUG | Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods. |
Inclusion Criteria: * Patient is a male, or a female who is unlikely to conceive, as indicated by meeting at least one of the following conditions: (a) Patient is a male.(b) Patient is a female of reproductive potential and either agrees to remain abstinent (if this form of birth control is accepte...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Enlicitide, Rosuvastatin |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | obicetrapib, ezetimibe daily |
| AstraZeneca PLC | AZN | 3 | PHASE2 | AZD0780, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| HeartFlow, Inc. | HTFL | 1 | N/A | Rosuvastatin |
Niacin laropiprant is an investigational small molecule being studied for dyslipidemia, hypercholesterolemia, type 2 diabetes mellitus, and primary hypercholesterolemia. It is being developed by Merck & Company, Inc. (MRK) as a potential treatment for these metabolic conditions.
Niacin laropiprant combines niacin, which affects lipid metabolism, with laropiprant, a prostaglandin D2 receptor antagonist. The laropiprant component is intended to reduce the flushing side effect associated with niacin therapy. This combination is being studied for its effects on lipid levels in patients with dyslipidemia and related conditions.
Niacin laropiprant is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is an investigational combination product being evaluated for metabolic indications.
Niacin laropiprant is in Phase 1 clinical development. It has completed three clinical trials, including Phase 1, Phase 2, and Phase 3 studies, but is not approved by the FDA and remains investigational. All completed trials have finished, with no active trials currently ongoing.
Niacin laropiprant has completed three clinical trials: NCT00111891, a Phase 2 study in dyslipidemia with 575 participants; NCT00269204, a Phase 3 study in primary hypercholesterolaemia and mixed hyperlipidaemia with 1620 participants; and NCT00944645, a Phase 1 bioequivalence study in dyslipidemia with 188 participants. All trials are completed.
Yes, niacin laropiprant is also known as MK0524A, which is the combination of extended release niacin and laropiprant. Clinical trials reference MK0524A in their titles, including NCT00944645 and NCT00961636, which study this combination product for dyslipidemia.