Trial Outcomes & Findings for A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH) (NCT NCT05952869)
NCT ID: NCT05952869
Last Updated: 2026-02-24
Results Overview
An AE was defined as 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
303 participants
Primary outcome timeframe
Up to 64 weeks (8 weeks postdose)
Results posted on
2026-02-24
Participant Flow
Participant milestones
| Measure |
Enlicitide Decanoate
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
101
|
|
Overall Study
COMPLETED
|
196
|
97
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Enlicitide Decanoate
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
Baseline characteristics by cohort
| Measure |
Enlicitide Decanoate
n=202 Participants
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=101 Participants
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 Years
STANDARD_DEVIATION 13.4 • n=58 Participants
|
51.4 Years
STANDARD_DEVIATION 13.9
|
52.4 Years
STANDARD_DEVIATION 13.5 • n=1 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=58 Participants
|
47 Participants
|
155 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=58 Participants
|
54 Participants
|
148 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=58 Participants
|
24 Participants
|
64 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
156 Participants
n=58 Participants
|
73 Participants
|
229 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=58 Participants
|
4 Participants
|
10 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=58 Participants
|
19 Participants
|
50 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=58 Participants
|
1 Participants
|
9 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
144 Participants
n=58 Participants
|
67 Participants
|
211 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=58 Participants
|
14 Participants
|
33 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Baseline Low-density Lipoprotein Cholesterol (LDL-C)
|
120.7 mg/dL
STANDARD_DEVIATION 38.2 • n=58 Participants
|
115.6 mg/dL
STANDARD_DEVIATION 46.1
|
119.0 mg/dL
STANDARD_DEVIATION 41.0 • n=1 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: All participants who have received at least 1 dose of double-blind study intervention and have data for both timepoints.
Blood samples were collected at baseline and at Week 24 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.
Outcome measures
| Measure |
Enlicitide Decanoate
n=198 Participants
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=96 Participants
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
|
-58.2 Percent Change
Standard Deviation 28.0
|
2.6 Percent Change
Standard Deviation 23.6
|
PRIMARY outcome
Timeframe: Up to 64 weeks (8 weeks postdose)Population: All participants who received at least 1 dose of study treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
An AE was defined as 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.
Outcome measures
| Measure |
Enlicitide Decanoate
n=202 Participants
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=101 Participants
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
157 Participants
|
77 Participants
|
PRIMARY outcome
Timeframe: Up to 56 weeksPopulation: All participants who received at least 1 dose of study treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment.
An AE was defined as 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.
Outcome measures
| Measure |
Enlicitide Decanoate
n=202 Participants
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=101 Participants
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: All participants who have received at least 1 dose of double-blind study intervention and have data for both timepoints.
Blood samples were collected at baseline and at Week 52 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.
Outcome measures
| Measure |
Enlicitide Decanoate
n=193 Participants
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=94 Participants
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Mean Percent Change From Baseline in LDL-C at Week 52
|
-55.3 Percent Change
Standard Deviation 27.9
|
8.7 Percent Change
Standard Deviation 33.0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants who have received at least 1 dose of double-blind study intervention and have data for both timepoints.
Blood samples were collected at baseline and at Week 24 to determine mean percent change in non-HDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline non-HDL-C as a covariate.
Outcome measures
| Measure |
Enlicitide Decanoate
n=198 Participants
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=96 Participants
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
|
-52.3 Percent Change
Standard Deviation 26.9
|
2.1 Percent Change
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants who have received at least 1 dose of double-blind study intervention and have data for both timepoints.
Blood samples were collected at baseline and at Week 24 to determine mean percent change in ApoB. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline ApoB as a covariate.
Outcome measures
| Measure |
Enlicitide Decanoate
n=197 Participants
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=97 Participants
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
|
-48.2 Percent Change
Standard Deviation 23.6
|
1.8 Percent Change
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants who have received at least 1 dose of double-blind study intervention and have data for both timepoints.
Blood samples were collected at baseline and at Week 24 to determine percent change in Lp(a). For percent change in Lp(a) at Week 24, the two treatment groups were analyzed using the Wilcoxon signed rank test with Hodges-Lehmann estimation.
Outcome measures
| Measure |
Enlicitide Decanoate
n=196 Participants
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=96 Participants
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24
|
-24.7 Percent Change
Interval -78.1 to 170.6
|
-1.6 Percent Change
Interval -47.4 to 67.0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants who have received at least 1 dose of double-blind study intervention and have baseline data.
Blood samples were collected at baseline and at Week 24 to determine the percentage of participants who had LDL-C \<70 mg/dL and ≥50% reduction from baseline. The two treatment groups were analyzed based on the Miettinen and Nurminen method for the difference in percentage.
Outcome measures
| Measure |
Enlicitide Decanoate
n=202 Participants
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=101 Participants
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24
|
70.8 Percentage of Participants
|
1.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants who have received at least 1 dose of double-blind study intervention and have baseline data.
Blood samples were collected at baseline and at Week 24 to determine the percentage of participants who had LDL-C \<55 mg/dL and ≥50% reduction from baseline. The two treatment groups were analyzed based on the Miettinen and Nurminen method for the difference in percentage.
Outcome measures
| Measure |
Enlicitide Decanoate
n=202 Participants
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=101 Participants
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24
|
67.3 Percentage of Participants
|
1.0 Percentage of Participants
|
Adverse Events
Enlicitide Decanoate
Serious events: 9 serious events
Other events: 102 other events
Deaths: 1 deaths
Placebo
Serious events: 4 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enlicitide Decanoate
n=202 participants at risk
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=101 participants at risk
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/202 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.99%
1/101 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/202 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.99%
1/101 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/202 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.99%
1/101 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
General disorders
Death
|
0.50%
1/202 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.00%
0/101 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.50%
1/202 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.00%
0/101 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Infections and infestations
Oral infection
|
0.00%
0/202 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.99%
1/101 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Infections and infestations
Pneumonia
|
2.0%
4/202 • Number of events 4 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.00%
0/101 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.50%
1/202 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.00%
0/101 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.50%
1/202 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.00%
0/101 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Nervous system disorders
Ischaemic stroke
|
0.50%
1/202 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.00%
0/101 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Nervous system disorders
Presyncope
|
0.50%
1/202 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.00%
0/101 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Product Issues
Device dislocation
|
0.00%
0/202 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.99%
1/101 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.50%
1/202 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.00%
0/101 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/202 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
0.99%
1/101 • Number of events 1 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
Other adverse events
| Measure |
Enlicitide Decanoate
n=202 participants at risk
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
|
Placebo
n=101 participants at risk
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
15/202 • Number of events 15 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
2.0%
2/101 • Number of events 2 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Gastrointestinal disorders
Nausea
|
7.9%
16/202 • Number of events 19 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
6.9%
7/101 • Number of events 8 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Infections and infestations
COVID-19
|
4.0%
8/202 • Number of events 8 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
10.9%
11/101 • Number of events 11 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Infections and infestations
Influenza
|
8.4%
17/202 • Number of events 21 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
8.9%
9/101 • Number of events 9 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
19/202 • Number of events 25 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
7.9%
8/101 • Number of events 10 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
10/202 • Number of events 12 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
5.9%
6/101 • Number of events 8 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
7.9%
16/202 • Number of events 19 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
4.0%
4/101 • Number of events 5 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
6/202 • Number of events 8 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
5.9%
6/101 • Number of events 6 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Nervous system disorders
Dizziness
|
6.9%
14/202 • Number of events 14 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
4.0%
4/101 • Number of events 5 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
|
Nervous system disorders
Headache
|
7.9%
16/202 • Number of events 19 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
6.9%
7/101 • Number of events 18 • Up to 64 weeks.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. One participant received enlicitide decanoate at 56 weeks outside of protocol-specified duration of treatment and was followed for AEs up to 64 weeks (per protocol, 8 weeks postdose).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Authorship will be determined in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER