Trial Outcomes & Findings for HEALEY ALS Platform Trial - Regimen C CNM-Au8 (NCT NCT04414345)

Last Updated: 2023-07-25

Results Overview

Change in disease severity as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score using a Bayesian repeated measures model that accounts for loss to follow-up due to mortality. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

161 participants

Primary outcome timeframe

Baseline to 24 Weeks

Results posted on

2023-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	CNM-Au8 Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily CNM-Au8: Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily	Matching Placebo Administration: Oral Dosage: 2 bottles daily Matching Placebo: Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily
Overall Study STARTED	120	41
Overall Study COMPLETED	110	35
Overall Study NOT COMPLETED	10	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Number analyzed in row differs from overall number due to missing data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CNM-Au8 n=120 Participants Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily CNM-Au8: Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily	Matching Placebo n=41 Participants Administration: Oral Dosage: 2 bottles daily Matching Placebo: Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily	Total n=161 Participants Total of all reporting groups
Baseline Edaravone Use No	92 Participants n=120 Participants	31 Participants n=41 Participants	123 Participants n=161 Participants
Baseline Edaravone Use Yes	28 Participants n=120 Participants	10 Participants n=41 Participants	38 Participants n=161 Participants
Age, Continuous	58.2 years STANDARD_DEVIATION 9.99 • n=120 Participants	57.0 years STANDARD_DEVIATION 11.72 • n=41 Participants	57.9 years STANDARD_DEVIATION 10.43 • n=161 Participants
Sex: Female, Male Female	49 Participants n=120 Participants	12 Participants n=41 Participants	61 Participants n=161 Participants
Sex: Female, Male Male	71 Participants n=120 Participants	29 Participants n=41 Participants	100 Participants n=161 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=120 Participants	3 Participants n=41 Participants	6 Participants n=161 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	116 Participants n=120 Participants	38 Participants n=41 Participants	154 Participants n=161 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=120 Participants	0 Participants n=41 Participants	1 Participants n=161 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=120 Participants	0 Participants n=41 Participants	0 Participants n=161 Participants
Race (NIH/OMB) Asian	0 Participants n=120 Participants	0 Participants n=41 Participants	0 Participants n=161 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=120 Participants	0 Participants n=41 Participants	0 Participants n=161 Participants
Race (NIH/OMB) Black or African American	0 Participants n=120 Participants	2 Participants n=41 Participants	2 Participants n=161 Participants
Race (NIH/OMB) White	120 Participants n=120 Participants	38 Participants n=41 Participants	158 Participants n=161 Participants
Race (NIH/OMB) More than one race	0 Participants n=120 Participants	1 Participants n=41 Participants	1 Participants n=161 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=120 Participants	0 Participants n=41 Participants	0 Participants n=161 Participants
El Escorial Diagnosis Clinically Definite ALS	58 Participants n=120 Participants	14 Participants n=41 Participants	72 Participants n=161 Participants
El Escorial Diagnosis Clinically Probable ALS	43 Participants n=120 Participants	10 Participants n=41 Participants	53 Participants n=161 Participants
El Escorial Diagnosis Clinically Probable ALS - Laboratory Supported	16 Participants n=120 Participants	16 Participants n=41 Participants	32 Participants n=161 Participants
El Escorial Diagnosis Clinically Possible ALS	3 Participants n=120 Participants	1 Participants n=41 Participants	4 Participants n=161 Participants
Time Since Symptom onset at Baseline	22.7 months STANDARD_DEVIATION 8.64 • n=120 Participants	21.9 months STANDARD_DEVIATION 8.49 • n=41 Participants	22.5 months STANDARD_DEVIATION 8.58 • n=161 Participants
Delay in ALS Symptom Onset and Diagnosis	10.5 months STANDARD_DEVIATION 5.92 • n=120 Participants	10.0 months STANDARD_DEVIATION 5.64 • n=41 Participants	10.3 months STANDARD_DEVIATION 5.84 • n=161 Participants
ALS Onset Location Bulbar	18 Participants n=120 Participants	6 Participants n=41 Participants	24 Participants n=161 Participants
ALS Onset Location Limb	102 Participants n=120 Participants	35 Participants n=41 Participants	137 Participants n=161 Participants
Baseline Riluzole Use No	26 Participants n=120 Participants	9 Participants n=41 Participants	35 Participants n=161 Participants
Baseline Riluzole Use Yes	94 Participants n=120 Participants	32 Participants n=41 Participants	126 Participants n=161 Participants
ALSFRS-R Total Score	34.3 scores on a scale STANDARD_DEVIATION 6.56 • n=120 Participants	36.1 scores on a scale STANDARD_DEVIATION 5.91 • n=41 Participants	34.7 scores on a scale STANDARD_DEVIATION 6.43 • n=161 Participants
Change in ALSFRS-R prior to Baseline	0.72 points per month STANDARD_DEVIATION 0.535 • n=120 Participants	0.60 points per month STANDARD_DEVIATION 0.353 • n=41 Participants	0.69 points per month STANDARD_DEVIATION 0.497 • n=161 Participants
SVC	75.2 percent predicted STANDARD_DEVIATION 16.08 • n=116 Participants • Number analyzed in row differs from overall number due to missing data.	76.1 percent predicted STANDARD_DEVIATION 16.79 • n=40 Participants • Number analyzed in row differs from overall number due to missing data.	75.4 percent predicted STANDARD_DEVIATION 16.22 • n=156 Participants • Number analyzed in row differs from overall number due to missing data.
Kings Stage 1 Region with Neuromuscular Dysfunction	13 Participants n=120 Participants	9 Participants n=41 Participants	22 Participants n=161 Participants
Kings Stage 2 Regions with Neuromuscular Dysfunction	36 Participants n=120 Participants	11 Participants n=41 Participants	47 Participants n=161 Participants
Kings Stage 3 Regions with Neuromuscular Dysfunction	41 Participants n=120 Participants	7 Participants n=41 Participants	48 Participants n=161 Participants
Kings Stage 4a/b Nutritional/Respiratory Failure	1 Participants n=120 Participants	0 Participants n=41 Participants	1 Participants n=161 Participants
Kings Stage 4b Respiratory Failure	29 Participants n=120 Participants	14 Participants n=41 Participants	43 Participants n=161 Participants
Weight	79.6 kg STANDARD_DEVIATION 16.74 • n=120 Participants	87.1 kg STANDARD_DEVIATION 20.38 • n=41 Participants	81.5 kg STANDARD_DEVIATION 17.97 • n=161 Participants
Body Mass Index	27.0 kg/m^2 STANDARD_DEVIATION 5.07 • n=120 Participants	28.4 kg/m^2 STANDARD_DEVIATION 5.47 • n=41 Participants	27.4 kg/m^2 STANDARD_DEVIATION 5.20 • n=161 Participants
Serum Creatinine Concentration	0.7 mg/dL STANDARD_DEVIATION 0.17 • n=120 Participants	0.7 mg/dL STANDARD_DEVIATION 0.20 • n=41 Participants	0.7 mg/dL STANDARD_DEVIATION 0.18 • n=161 Participants
Neurofilament Light (NfL) Protein in Serum	91.6 ng/L STANDARD_DEVIATION 58.04 • n=117 Participants • Number analyzed in row differs from overall number due to missing data.	85.3 ng/L STANDARD_DEVIATION 71.63 • n=39 Participants • Number analyzed in row differs from overall number due to missing data.	90.0 ng/L STANDARD_DEVIATION 61.53 • n=156 Participants • Number analyzed in row differs from overall number due to missing data.

PRIMARY outcome

Timeframe: Baseline to 24 Weeks

Population: Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A Zilucoplan (NCT04436497), Regimen B Verdiperstat (NCT04436510), and Regimen D Pridopidine (NCT04615923) contributed placebo participants into the shared placebo cohort used for analysis.

Outcome measures

Outcome measures
Measure	CNM-Au8 n=120 Participants Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily CNM-Au8: Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily	Matching Placebo n=164 Participants Administration: Oral Dosage: 2 bottles daily Matching Placebo: Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily
Disease Progression as Assessed by the ALSFRS-R Total Score	-1.01 ALSFRS-R total score points per month Standard Deviation 0.075	-1.03 ALSFRS-R total score points per month Standard Deviation 0.072

PRIMARY outcome

Timeframe: Baseline to 24 Weeks

Mortality is defined as death or death equivalent. A participant is determined to meet the criteria of death equivalent if permanent assisted ventilation (PAV) is used for more than 22 hours per day for more than seven days in a row. The rate of mortality was estimated from a Bayesian shared-parametric model that assumed exponentially distributed survival times.

Outcome measures

Outcome measures
Measure	CNM-Au8 n=120 Participants Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily CNM-Au8: Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily	Matching Placebo n=164 Participants Administration: Oral Dosage: 2 bottles daily Matching Placebo: Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily
Mortality Event Rate	0.006 events per month Standard Deviation 0.002	0.007 events per month Standard Deviation 0.002

SECONDARY outcome

Timeframe: Baseline to 24 Weeks

Change in respiratory function as assessed by slow vital capacity (SVC).

Outcome measures

Outcome measures
Measure	CNM-Au8 n=120 Participants Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily CNM-Au8: Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily	Matching Placebo n=164 Participants Administration: Oral Dosage: 2 bottles daily Matching Placebo: Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily
Respiratory Function	-9.32 percent change Standard Error 1.362	-8.53 percent change Standard Error 1.146

SECONDARY outcome

Timeframe: Baseline to 24 Weeks

Change in muscle strength as measured isometrically using hand-held dynamometry (HHD).

Outcome measures

Outcome measures
Measure	CNM-Au8 n=120 Participants Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily CNM-Au8: Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily	Matching Placebo n=164 Participants Administration: Oral Dosage: 2 bottles daily Matching Placebo: Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily
Muscle Strength	-27.54 percent change Standard Error 2.647	-24.44 percent change Standard Error 2.260

SECONDARY outcome

Timeframe: 24 Weeks

Population: Outcome measure data was analyzed using the Full Analysis Set (FAS), which includes shared placebo from other regimens.

The number of participants who died or met the criterion for a death equivalent from the date of their baseline visit to the end of the Week 24visit window (generally 175 days after baseline). The death equivalent criterion is use of permanent assisted ventilation (PAV) for more than 22hours per day for more than 7 days in a row.

Outcome measures

Outcome measures
Measure	CNM-Au8 n=120 Participants Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily CNM-Au8: Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily	Matching Placebo n=164 Participants Administration: Oral Dosage: 2 bottles daily Matching Placebo: Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily
Number of Participants That Experienced Death or Death Equivalent	3 Participants	5 Participants

Adverse Events

CNM-Au8

Serious events: 16 serious events

Other events: 110 other events

Deaths: 4 deaths

Matching Placebo

Serious events: 7 serious events

Other events: 38 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Healey Center for ALS Project Management

Healey Center for ALS at Massachusetts General Hospital

Phone: 833-425-8257 (HALT ALS)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CNM-Au8 n=120 participants at risk Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily CNM-Au8: Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily	Matching Placebo n=41 participants at risk Administration: Oral Dosage: 2 bottles daily Matching Placebo: Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.2% 5/120 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.5% 3/120 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/120 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/120 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.
Infections and infestations COVID-19	0.83% 1/120 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Infections and infestations Cellulitis	0.00% 0/120 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.
Infections and infestations Implant site cellulitis	0.00% 0/120 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.
Infections and infestations Pneumonia bacterial	0.00% 0/120 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.
Infections and infestations Sepsis	0.83% 1/120 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Infections and infestations Urinary tract infection	0.00% 0/120 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.
Nervous system disorders Amyotrophic lateral sclerosis	1.7% 2/120 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Nervous system disorders Migraine	0.00% 0/120 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.
Nervous system disorders Syncope	0.83% 1/120 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Injury, poisoning and procedural complications Foot fracture	0.83% 1/120 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Injury, poisoning and procedural complications Post-traumatic pain	0.83% 1/120 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Injury, poisoning and procedural complications Rib fracture	0.83% 1/120 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
General disorders Chest pain	0.83% 1/120 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Gastrointestinal disorders Complication associated with device	0.83% 1/120 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Metabolism and nutrition disorders Failure to thrive	0.83% 1/120 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Metabolism and nutrition disorders Malnutrition	0.83% 1/120 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/120 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/120 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.
Vascular disorders Deep vein thrombosis	0.00% 0/120 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.

Measure	CNM-Au8 n=120 participants at risk Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily CNM-Au8: Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily	Matching Placebo n=41 participants at risk Administration: Oral Dosage: 2 bottles daily Matching Placebo: Drug: Matching Placebo Administration: Oral Dosage: 2 bottles daily
Nervous system disorders Muscular weakness	20.0% 24/120 • Number of events 39 • Up to 35 weeks after participant signed Master Protocol consent.	29.3% 12/41 • Number of events 17 • Up to 35 weeks after participant signed Master Protocol consent.
Nervous system disorders Headache	14.2% 17/120 • Number of events 26 • Up to 35 weeks after participant signed Master Protocol consent.	9.8% 4/41 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent.
Nervous system disorders Neuromyopathy	11.7% 14/120 • Number of events 21 • Up to 35 weeks after participant signed Master Protocol consent.	14.6% 6/41 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent.
Nervous system disorders Dysarthria	12.5% 15/120 • Number of events 16 • Up to 35 weeks after participant signed Master Protocol consent.	4.9% 2/41 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent.
Nervous system disorders Tension headache	5.8% 7/120 • Number of events 10 • Up to 35 weeks after participant signed Master Protocol consent.	9.8% 4/41 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent.
Nervous system disorders Amyotrophic lateral sclerosis	5.0% 6/120 • Number of events 8 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Gastrointestinal disorders Diarrhoea	19.2% 23/120 • Number of events 33 • Up to 35 weeks after participant signed Master Protocol consent.	9.8% 4/41 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent.
Gastrointestinal disorders Nausea	14.2% 17/120 • Number of events 21 • Up to 35 weeks after participant signed Master Protocol consent.	14.6% 6/41 • Number of events 8 • Up to 35 weeks after participant signed Master Protocol consent.
Gastrointestinal disorders Constipation	14.2% 17/120 • Number of events 19 • Up to 35 weeks after participant signed Master Protocol consent.	7.3% 3/41 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent.
Gastrointestinal disorders Dysphagia	8.3% 10/120 • Number of events 10 • Up to 35 weeks after participant signed Master Protocol consent.	12.2% 5/41 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent.
Gastrointestinal disorders Vomiting	5.0% 6/120 • Number of events 9 • Up to 35 weeks after participant signed Master Protocol consent.	4.9% 2/41 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent.
Injury, poisoning and procedural complications Fall	21.7% 26/120 • Number of events 44 • Up to 35 weeks after participant signed Master Protocol consent.	31.7% 13/41 • Number of events 17 • Up to 35 weeks after participant signed Master Protocol consent.
Injury, poisoning and procedural complications Skin laceration	5.0% 6/120 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent.	4.9% 2/41 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent.
Injury, poisoning and procedural complications Post-traumatic pain	2.5% 3/120 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent.	7.3% 3/41 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent.
General disorders Fatigue	10.8% 13/120 • Number of events 17 • Up to 35 weeks after participant signed Master Protocol consent.	22.0% 9/41 • Number of events 9 • Up to 35 weeks after participant signed Master Protocol consent.
General disorders Oedema peripheral	5.8% 7/120 • Number of events 13 • Up to 35 weeks after participant signed Master Protocol consent.	9.8% 4/41 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.8% 13/120 • Number of events 14 • Up to 35 weeks after participant signed Master Protocol consent.	7.3% 3/41 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent.
Respiratory, thoracic and mediastinal disorders Cough	5.8% 7/120 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent.	2.4% 1/41 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 6/120 • Number of events 12 • Up to 35 weeks after participant signed Master Protocol consent.	7.3% 3/41 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent.
Infections and infestations Urinary tract infection	8.3% 10/120 • Number of events 13 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Infections and infestations Sinusitis	5.0% 6/120 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Infections and infestations COVID-19	1.7% 2/120 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent.	7.3% 3/41 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent.
Investigations Weight Decreased	1.7% 2/120 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent.	12.2% 5/41 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent.
Psychiatric disorders Depression	2.5% 3/120 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent.	9.8% 4/41 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent.
Skin and subcutaneous tissue disorders Pruritus	5.0% 6/120 • Number of events 8 • Up to 35 weeks after participant signed Master Protocol consent.	0.00% 0/41 • Up to 35 weeks after participant signed Master Protocol consent.
Metabolism and nutrition disorders Decreased Appetite	4.2% 5/120 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent.	7.3% 3/41 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent.