Trial Outcomes & Findings for A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04 (NCT NCT03383146)

Last Updated: 2021-11-23

Results Overview

Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

450 participants

Primary outcome timeframe

Up to 52 weeks

Results posted on

2021-11-23

Participant Flow

Participants who completed the placebo run-in of relamorelin studies: RLM-MD-01 \[NCT03285308\] and RLM-MD-02 \[NCT03426345\] were eligible to rollover to this study. De novo (New) participants, who had not participated in the previous studies, were also eligible for enrollment.

Participant milestones

Participant milestones
Measure	Placebo Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Overall Study STARTED	148	302
Overall Study Safety Population	145	299
Overall Study Run-in Period	91	207
Overall Study COMPLETED	63	118
Overall Study NOT COMPLETED	85	184

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Overall Study Screen Failure	1	0
Overall Study Adverse Event	6	18
Overall Study Lack of Efficacy	0	3
Overall Study Withdrawal by Subject	20	36
Overall Study Lost to Follow-up	5	15
Overall Study Death	0	2
Overall Study Physician Decision	0	1
Overall Study Protocol Deviation	1	8
Overall Study Study Terminated by the Sponsor	48	95
Overall Study Reason not Specified	4	6

Baseline Characteristics

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=148 Participants Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg n=302 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Total n=450 Participants Total of all reporting groups
Age, Continuous	57.0 years STANDARD_DEVIATION 12.37 • n=5 Participants	57.9 years STANDARD_DEVIATION 11.57 • n=7 Participants	57.6 years STANDARD_DEVIATION 11.84 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	224 Participants n=7 Participants	326 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	78 Participants n=7 Participants	124 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	50 Participants n=5 Participants	82 Participants n=7 Participants	132 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants	220 Participants n=7 Participants	318 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	53 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) White	109 Participants n=5 Participants	218 Participants n=7 Participants	327 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study

Population: Modified-intent-to-treat (mITT) Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.

Outcome measures

Outcome measures
Measure	Placebo n=147 Participants Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg n=295 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) Baseline	20.3 score on a scale Standard Deviation 6.70	19.7 score on a scale Standard Deviation 6.39
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) Change from Baseline to Week 12	-7.1 score on a scale Standard Deviation 8.82	-6.5 score on a scale Standard Deviation 7.80

PRIMARY outcome

Timeframe: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study

Population: mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.

Outcome measures

Outcome measures
Measure	Placebo n=147 Participants Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg n=295 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Change From Baseline to Week 52 in the Weekly Average DGSSS Baseline	20.3 score on a scale Standard Deviation 6.70	19.7 score on a scale Standard Deviation 6.39
Change From Baseline to Week 52 in the Weekly Average DGSSS Change from Baseline to Week 52	-10.7 score on a scale Standard Deviation 8.93	-8.6 score on a scale Standard Deviation 8.92

PRIMARY outcome

Timeframe: First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)

Population: Safety Population included all participants who received ≥1 administration of study treatment.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.

Outcome measures

Outcome measures
Measure	Placebo n=145 Participants Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg n=299 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)	105 Participants	221 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: Safety Population included all participants who received ≥1 administration of study treatment. Number analyzed is the number of participants with non-PCS Baseline values and at least one post-baseline assessment.

Outcome measures

Outcome measures
Measure	Placebo n=145 Participants Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg n=299 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN	2 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN	7 Participants	3 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Red Blood Cell Count (10^12/L):<0.9×LLN	2 Participants	10 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results White Blood Cell Count (10^9/L): <0.7×LLN	2 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Alanine Aminotransferase (Serum Glutamate-Pyruvate transaminase (SGPT)) (Unit (U)/L): ≥3.0×ULN	0 Participants	6 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Albumin (gram (g)/L): <0.9×LLN	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Alkaline Phosphatase (U/L): ≥3.0×ULN	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase (SGOT)) (U/L): ≥3.0×ULN	2 Participants	3 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Bicarbonate (HCO3) (millimole (mmol)/L): >1.1×ULN	3 Participants	2 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Bicarbonate (HCO3) (millimole (mmol)/L): >1.1×LLN	3 Participants	2 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Bicarbonate (HCO3) (millimole (mmol)/L): <0.9×LLN	6 Participants	6 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Bilirubin, Total (micromole (umol)/L): >1.5×ULN	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Blood Urea Nitrogen (mmol/L): >1.2×ULN	14 Participants	27 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Calcium (mmol/L): >1.1×ULN	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Chloride (mmol/L): <0.9×LLN	1 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Cholesterol, Total, Fasting (mmol/L): >1.6×ULN	2 Participants	5 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Creatinine (umol/L): >1.3×ULN	15 Participants	20 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN	22 Participants	52 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN	4 Participants	14 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glycohemoglobin A1C (%): Increase of ≥0.5%	95 Participants	247 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glycohemoglobin A1C (%): Increase of ≥1%	94 Participants	246 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Phosphorus (mmol/L): >1.1×ULN	13 Participants	5 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Phosphorus (mmol/L): <0.9×LLN	1 Participants	4 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Potassium (mmol/L): <0.9×LLN	1 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Protein, Total (g)/L): >1.1×ULN	1 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Hematocrit (RATIO): >1.1×Upper Limit of Normal Value (ULN)	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN)	5 Participants	14 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Hemoglobin (gram(g)/L): <0.9×LLN	10 Participants	20 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Lymphocytes Absolute Cell Count (10^9/(Liter(L)): >1.5×ULN	1 Participants	5 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN	2 Participants	9 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN	2 Participants	2 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Triglycerides, Fasting (mmol/L): ≥3.0×ULN	8 Participants	9 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Uric Acid (Urate) (umol/L): >1.1×ULN	17 Participants	37 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Uric Acid (Urate) (umol/L): <0.9×LLN	1 Participants	9 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: Safety Population included all participants who received ≥1 administration of study treatment.

Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.

Outcome measures

Outcome measures
Measure	Placebo n=145 Participants Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg n=299 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Number of Participants With Clinically Meaningful Trends for Vital Signs	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: Safety Population included all participants who received ≥1 administration of study treatment.

A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

Outcome measures

Outcome measures
Measure	Placebo n=145 Participants Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg n=299 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: Safety Population included all participants who received ≥1 administration of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=145 Participants Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg n=299 Participants Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c)	94 Participants	246 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)

Population: Safety Population included all participants who received ≥1 administration of double-blind study treatment (N=299 in the Relamorelin 10 μg arm). Anti-relamorelin antibody testing was only done for those participants who received treatment with relamorelin. Number analyzed is the number of participants with data available at the given timepoint. Due to a laboratory issue not all positive screening tests were confirmed.

A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.

Outcome measures

Outcome measures
Measure	Placebo n=299 Participants Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Baseline) · Negative	127 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Baseline) · Positive	39 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Baseline) · Negative	5 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Baseline) · Positive	0 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Day 84) · Negative	73 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Day 84) · Positive	23 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Day 84) · Negative	6 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Day 84) · Positive	1 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Day 364) · Positive	4 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Unscheduled) · Positive	0 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Day 364) · Negative	10 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (End of Treatment) · Negative	20 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (End of Treatment) · Positive	6 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (End of Treatment) · Negative	1 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (End of Treatment) · Positive	0 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Unscheduled) · Negative	2 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Unscheduled) · Positive	1 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Unscheduled) · Negative	1 Participants	—

Adverse Events

Placebo

Serious events: 21 serious events

Other events: 37 other events

Deaths: 0 deaths

Relamorelin 10 μg

Serious events: 43 serious events

Other events: 82 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=145 participants at risk Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.	Relamorelin 10 μg n=299 participants at risk Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in.
Gastrointestinal disorders Diarrhoea	9.7% 14/145 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.	7.0% 21/299 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.
Infections and infestations Urinary tract infection	6.2% 9/145 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.	9.4% 28/299 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	5.5% 8/145 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.	5.0% 15/299 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.6% 11/145 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.	6.0% 18/299 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.
Nervous system disorders Headache	4.8% 7/145 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.	5.0% 15/299 • First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) All-Cause Mortality included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 administration of study treatment.

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER