Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Efinopegdutide · 6 trials · 11 indications
Liver fat content (LFC) was measured with liver images taken by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) and analyzed by blinded independent central review (BICR). Relative Reduction from Baseline to Week 28 = (Baseline - Week 28) / Baseline x 100%. Least Squares (LS) Mean relative reduction from baseline in LFC is presented.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE is presented.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who discontinued study intervention due to an AE is presented.
Researchers will measure the change in the amount of fat in the liver using magnetic resonance imaging (MRI) after about 7 months of treatment. The change in MRI-Estimated proton density fat fraction (PDFF) will be measured from baseline to 28 weeks.
An AE is a health problem that happens or worsens during a study. The percentage of participants who stop study treatment due to an AE will be reported.
The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) is used to assess treatment response. The NASH CRN scoring scales are: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution is defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Blood samples will be collected to determine the Cmax of Efinopegdutide.
Blood samples will be collected to determine the Tmax of Efinopegdutide.
Blood samples will be collected to determine the AUC0-last of Efinopegdutide.
Blood samples will be collected to determine the AUC0-Inf of Efinopegdutide.
Blood samples will be collected to determine the t1/2 of Efinopegdutide.
Blood samples will be collected to determine the CL/F of Efinopegdutide.
Blood samples will be collected to determine the Vz/F of Efinopegdutide.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Blood samples will be collected to determine the Cmax of Efinopegdutide.
Blood samples will be collected to determine the Tmax of Efinopegdutide.
Blood samples will be collected to determine the AUC0-tau of Efinopegdutide.
Blood samples will be collected to determine the CL/F of Efinopegdutide.
Blood samples will be collected to determine the Vz/F of Efinopegdutide.
Blood samples will be collected to determine the Ctrough of Efinopegdutide.
Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.
Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-last.
Blood samples collected at multiple timepoints post-dose were used to determine the Cmax.
Blood samples collected at multiple timepoints post-dose were used to determine the Tmax of efinopegdutide.
Blood samples collected at multiple timepoints post-dose were used to determine the t1/2.
Blood samples collected at multiple timepoints post-dose were used to determine the CL/F.
Blood samples collected at multiple timepoints post-dose were used to determine the Vz/F.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Blood samples will be collected to determine the Cmax of efinopegdutide when administered as a single dose
Blood samples will be collected to determine the Tmax of efinopegdutide when administered as a single dose
Blood samples will be collected to determine the AUC0-last of efinopegdutide when administered as a single dose
Blood samples will be collected to determine the AUC0-inf of efinopegdutide when administered as a single dose
Blood samples will be collected to determine the t1/2 of efinopegdutide when administered as a single dose
Blood samples will be collected to determine the CL of efinopegdutide when administered as a single dose
Blood samples will be collected to determine the Vz of efinopegdutide when administered as a single dose
Blood samples will be collected to determine the Cmax of efinopegdutide when multiple doses are administered
Blood samples will be collected to determine the Cmin of efinopegdutide when multiple doses are administered
Blood samples will be collected to determine the Tmax of efinopegdutide when multiple doses are administered
Blood samples will be collected to determine the t1/2 of efinopegdutide when multiple doses are administered
Blood samples will be collected to determine the AUC0-last of efinopegdutide when multiple doses are administered
Blood samples will be collected to determine the CL of efinopegdutide when multiple doses are administered
Blood samples will be collected to determine the Vss of efinopegdutide when multiple doses are administered
Blood samples will be collected to determine the AUC0 to tau of efinopegdutide when multiple doses are administered
| Arm | Type | Description |
|---|---|---|
| Efinopegdutide Q1W 10 mg | ACTIVE_COMPARATOR | Participants will receive efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. |
| Efinopegdutide Q2W 10 mg | EXPERIMENTAL | Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. |
| Efinopegdutide Q2W 15 mg | EXPERIMENTAL | Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks. |
| Efinopegdutide | EXPERIMENTAL | Participants will start efinopegdutide once a week at the lowest dose level. Then, the dose level will go up every month for three months until they are getting the highest dose level. Efinopegdutide is given as an injection under the skin (subcutaneous injection) for 28 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo once a week. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine. Placebo is given as an injection under the skin (subcutaneous injection) for 28 weeks. |
| Efinopegdutide 4mg | EXPERIMENTAL | Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks. |
| Efinopegdutide 7mg | EXPERIMENTAL | Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks. |
| Efinopegdutide 10mg | EXPERIMENTAL | Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks. |
| Semaglutide 2.4 mg | ACTIVE_COMPARATOR | Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks. |
| Part 1: Efinopegdutide | EXPERIMENTAL | Part 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Part 1: Participants receive a single SC dose of placebo. |
| Part 2: Efinopegdutide | EXPERIMENTAL | Part 2: Participants receive multiple SC doses of efinopegdutide titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of efinopegdutide, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Part 2: Participants receive multiple SC doses of Placebo titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of Placebo, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83. |
| Efinopegdutide in Participants with Moderate Hepatic Impairment | EXPERIMENTAL | Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection. |
| Efinopegdutide in Participants with Severe Hepatic Impairment | EXPERIMENTAL | Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
| Efinopegdutide in Healthy-Matched Control Group | EXPERIMENTAL | Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
| Efinopegdutide Low Dose | EXPERIMENTAL | Participants receive low dose efinopegdutide at a single dose on day 1 |
| Efinopegdutide Medium dose | EXPERIMENTAL | Participants receive medium dose efinopegdutide at a single dose on day 1 |
| Efinopegdutide High Dose | EXPERIMENTAL | Participants receive high dose efinopegdutide at a single dose on day 1 |
| Efinopegdutide Multiple Dose | EXPERIMENTAL | Participants receive multiple doses of efinopegdutide over 78 days |
| Name | Type | Description |
|---|---|---|
| Efinopegdutide | DRUG | SC injections in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg in all arms and 15 mg in the Efinopegdutide Q2W 15 mg arm |
| Placebo | COMBINATION_PRODUCT | Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks. |
| Semaglutide | DRUG | SC injection in a dose-escalation regimen of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg |
| Acetaminophen | DRUG | Oral solution |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has body mass index (BMI) ≥25 kg/m\^2 (≥23 kg/m\^2 for Asian participants) AND has stable weight, defined as ≤5% gain or loss of body weight for at least 3 months before screening * Has no history of ty...
Efinopegdutide is an investigational small molecule being studied for non-alcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD), and metabolic dysfunction-associated steatotic liver disease (MASLD). It is also being evaluated in healthy volunteers and in people with hepatic impairment or compensated cirrhosis due to steatohepatitis.
Efinopegdutide is a peptide-based small molecule, classified under the -tide (peptide) target class. Its specific molecular target is not disclosed in the available clinical trial information, so its precise mechanism of action is not detailed here.
Efinopegdutide is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug for liver diseases such as NASH and NAFLD.
Efinopegdutide is in clinical development, with trials listed as Phase 1 and Phase 2. The Phase 2 study is active but not recruiting, while the Phase 1 studies have been completed. It is not FDA approved and remains investigational.
Efinopegdutide has been studied in several trials, including NCT06052566 in participants with hepatic impairment, NCT06465186 in people with compensated cirrhosis due to steatohepatitis, NCT06701305 in healthy obese participants, and NCT06836037 in healthy Chinese volunteers. These trials cover Phase 1 and Phase 2 stages.
Yes, Efinopegdutide is also known as MK-6024. Clinical trial titles reference MK-6024 in studies such as NCT06052566 and NCT06465186, confirming that these names refer to the same investigational drug.