Trial Outcomes & Findings for Study in Major Depressive Disorder With NMRA-335140 (BTRX-335140) vs Placebo (NCT NCT04221230)

NCT ID: NCT04221230

Last Updated: 2025-05-29

Results Overview

The HAMD-17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (9 items) or 0 and 2 (8 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represents more severe condition. Baseline is defined as the latest non-missing measurement prior to or within 1 hour of the first administration of study drug. Change from Baseline is defined as post dose visit value minus Baseline value.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 204 participants
• Primary outcome timeframe: Baseline and at Week 8
• Results posted on: 2025-05-29

Participant Flow

This was an 8-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study that evaluated the effects of NMRA-335140 on symptoms of depression in adult participants with major depressive disorder (MDD) and symptoms of anhedonia and anxiety after 8 weeks of double-blind treatment.

A total of 204 participants were enrolled in the study.

Participant milestones

Measure	NMRA-335140 Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Overall Study STARTED	102	102
Overall Study COMPLETED	72	64
Overall Study NOT COMPLETED	30	38

Reasons for withdrawal

Measure	NMRA-335140 Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Overall Study Lost to Follow-up	12	12
Overall Study Protocol Violation	2	2
Overall Study Adverse Event	0	8
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	13	11
Overall Study Non-Compliance with Study Drug	1	1
Overall Study Unsatisfactory Therapeutic Effect	0	1
Overall Study Pregnancy	0	1
Overall Study Other	1	2

Baseline Characteristics

Study in Major Depressive Disorder With NMRA-335140 (BTRX-335140) vs Placebo

Baseline characteristics by cohort

Measure	NMRA-335140 n=102 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=102 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.	Total n=204 Participants Total of all reporting groups
Age, Continuous	41.4 Years STANDARD_DEVIATION 13.12 • n=5 Participants	40.9 Years STANDARD_DEVIATION 13.44 • n=7 Participants	41.2 Years STANDARD_DEVIATION 13.25 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	72 Participants n=7 Participants	144 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	89 Participants n=5 Participants	86 Participants n=7 Participants	175 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) White	63 Participants n=5 Participants	64 Participants n=7 Participants	127 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at Week 8

Population: Final Efficacy population comprised of the Full Efficacy population but excluded 5 subjects from a single site due to GCP noncompliance that compromised data integrity. Only those participants with data available at specified time points has been presented.

The HAMD-17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (9 items) or 0 and 2 (8 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represents more severe condition. Baseline is defined as the latest non-missing measurement prior to or within 1 hour of the first administration of study drug. Change from Baseline is defined as post dose visit value minus Baseline value.

Outcome measures

Measure	NMRA-335140 n=75 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=64 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Change From Baseline in Hamilton Depression Rating Scale (HAMD-17) Total Score at Weeks 8	-9.0 Scores on a scale Standard Error 0.73	-7.4 Scores on a scale Standard Error 0.79

SECONDARY outcome

Timeframe: At Week 8

Population: Final Efficacy Population. Only those participants with data available at specified timepoints has been presented.

The CGI-I scale is a clinician-rated instrument that measures the improvement of the participant's symptoms. It is a 7-point scale where a score of 1 indicates that the participants is "very much improved," a score of 4 indicates that the participant has experienced "no change, and a score of 7 indicates that the participant is "very much worse." The total score is the item response; lower scores indicate greater improvement.

Outcome measures

Measure	NMRA-335140 n=73 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=62 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Clinical Global Impression of Improvement (CGI-I) Score	2.4 Scores on a scale Standard Error 0.13	2.7 Scores on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline and at Week 8

Population: Final Efficacy Population.

The SHAPS is a self-report 14-item, instrument, developed for the assessment of hedonic capacity. Participants score whether they experience pleasure in performing a list of activities or experiences. Participants can rate the answers as "definitely/strongly agree", "agree", "disagree" or "strongly disagree". "Definitely agree" will be rated 1, "Agree" will be rated 2, "Disagree" will be rated 3, and "Definitely disagree" will be rated 4. The participant's item responses are summed to provide a total score ranging from 14 to 56. A higher total SHAPS score indicates higher levels of current anhedonia. Baseline is defined as the latest non-missing measurement prior to or within 1 hour of the first administration of study drug. Change from Baseline is defined as post dose visit value minus Baseline value.

Outcome measures

Measure	NMRA-335140 n=75 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=64 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score	-7.7 Scores on a scale Standard Error 0.81	-4.8 Scores on a scale Standard Error 0.88

SECONDARY outcome

Timeframe: Baseline and at Week 8

Population: Final Efficacy Population. Only those participants with data available at specified timepoints has been presented.

The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire with 2 subscales: anxiety and depression. Seven of the items are used to evaluate anxiety and 7 evaluate depression. Each item on the questionnaire is scored from 0 to 3. Therefore, the anxiety subscale (HADS-A) and the depression subscale (HADS-D) each range from 0 to 21. Higher scores indicate higher levels of anxiety and depression, respectively. Baseline is defined as the latest non-missing measurement prior to or within 1 hour of the first administration of study drug. Change from Baseline is defined as post dose visit value minus Baseline value.

Outcome measures

Measure	NMRA-335140 n=73 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=62 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscales (ie, Anxiety Subscale [HADS-A] and Depression Subscale [HADS-D]) Scores HADS-A Score	-3.6 Scores on a scale Standard Error 0.39	-3.3 Scores on a scale Standard Error 0.43
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscales (ie, Anxiety Subscale [HADS-A] and Depression Subscale [HADS-D]) Scores HADS-D Score	-4.8 Scores on a scale Standard Error 0.55	-4.3 Scores on a scale Standard Error 0.60

SECONDARY outcome

Timeframe: Baseline and at Week 8

Population: Final Efficacy Population. Only those participants with data available at specified timepoints has been presented.

The HAM-A was administered to assess severity of anxiety, its improvement during the course of treatment, and the timing of such improvement. This instrument was completed by qualified and trained investigator site raters based on a semi-structured interview of his/her assessment of the participant. The HAM-A is a 14-item scale to measure severity of different anxiety-related symptoms in participants. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree) with a total score range of 0 to 56 where higher score indicates greater symptom severity. Baseline is defined as the latest non-missing measurement prior to or within 1 hour of the first administration of study drug. Change from Baseline is defined as post dose visit value minus Baseline value.

Outcome measures

Measure	NMRA-335140 n=75 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=64 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score	-6.8 Scores on a scale Standard Error 0.66	-6.3 Scores on a scale Standard Error 0.71

SECONDARY outcome

Timeframe: Baseline and at Week 8

Population: Final Efficacy Population. Only those participants with data available at specified timepoints has been presented.

The Sheehan Disability Scale (SDS) is a 3-item self-rated questionnaire used to evaluate impairments in the domains of work/school, social life, and family life/home responsibility on a 10-point visual analog scale. In each domain of the overall scale, the minimum score is a 0 (indicating that symptoms have been 'not at all' disruptive to functioning) and the maximum score is a 10 (indicating that symptoms have been 'extremely' disruptive to functioning). The three items were summed into a single dimensional measure of global functional impairment with total score ranging from 0 (unimpaired) to 30 (highly impaired) with the highest scores representing the higher level of disability/greater functional impairment. SDS Total Score is calculated for subjects with all 3 domain scores (work/school, social, and family life) and an unmarked checkbox for "No work or school". Baseline is defined as Day 1. Change from Baseline is defined as the post dose visit value minus the Baseline value.

Outcome measures

Measure	NMRA-335140 n=56 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=48 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Change From Baseline in Sheehan Disability Scale (SDS) Scores	-9.5 Scores on a scale Standard Error 0.99	-7.9 Scores on a scale Standard Error 1.06

SECONDARY outcome

Timeframe: Baseline and at Week 8

Population: Final Efficacy Population. Only those participants with data available at specified timepoints has been presented.

The CGI-S is a clinician-rated instrument that measures the severity of depression at the time of assessment. This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. The score reflected the average severity level across the 7 days. The CGI-S is scored on a 7-point scale where a score of 1 indicates that the participant is normal, not at all ill, a score of 4 indicates that the participant is moderately ill, and a score of 7 indicates that the participant is among the most extremely ill participants. Baseline is defined as the latest non-missing measurement prior to or within 1 hour of the first administration of study drug.

Outcome measures

Measure	NMRA-335140 n=65 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=52 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Change From Baseline to Week 8 in Clinical Global Impression Scale - Severity (CGI-S) Scores	-1.4 Scores on a scale Standard Error 0.14	-1.1 Scores on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: At Week 8

Population: Final Efficacy Population. Only those participants with data available at specified timepoints has been presented

The HAMD-17 is a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (9 items) or 0 and 2 (8 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represented more severe condition. HAMD-17 response rate, where response is defined as ≥ 50% decrease in HAMD-17 total score from Baseline to Week 8.

Outcome measures

Measure	NMRA-335140 n=75 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=64 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Percentage of Participants With a HAMD-17 Response	46.7 Percentage of participants	28.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 8 Weeks

Population: Safety Population.

An AE is any event that was not present prior to the initiation of study treatment, or any event already present that worsens in either intensity or frequency following exposure to study treatment. A TEAE is any event that was not present prior to the initiation of study treatment, or any event already present that worsens in either intensity or frequency following exposure to study treatment. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the above outcomes.

Outcome measures

Measure	NMRA-335140 n=102 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=102 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Number of Participants Reporting >2% Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) Any TEAE	19 Participants	13 Participants
Number of Participants Reporting >2% Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) Any SAE	0 Participants	1 Participants
Number of Participants Reporting >2% Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) Any AESI	10 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 8 Weeks

Population: Safety Population.

Blood samples were collected for the analysis of hematology parameters - basophils, eosinophils, erythrocyte mean corpuscular hemoglobin, erythrocyte mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and reticulocytes

Outcome measures

Measure	NMRA-335140 n=102 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=102 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Number of Participants With Clinically Significant Changes in Hematology Parameters	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 8 Weeks

Population: Safety Population.

Blood samples were collected for the analysis of chemistry parameters - alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatine kinase, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, potassium, protein, sodium and urea nitrogen,

Outcome measures

Measure	NMRA-335140 n=102 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=102 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 8 Weeks

Population: Safety Population.

Urine samples were collected for the analysis of urinary parameters - Urinalysis White blood cell (WBC), urine dipstick bilirubin, blood, glucose, ketones, leukocyte esterase, nitrite, potential of Hydrogen (pH), protein, specific gravity and urobilinogen.

Outcome measures

Measure	NMRA-335140 n=102 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=102 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Number of Participants With Clinically Significant Changes in Urinary Parameters	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 8 Weeks

Population: Safety Population.

The following vital parameters were analyzed: diastolic blood pressure, systolic blood pressure, temperature, heart rate and respiratory rate.

Outcome measures

Measure	NMRA-335140 n=102 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=102 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Number of Participants With Clinically Significant Changes in Vital Parameters	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 8 Weeks

Population: Safety Population.

Electrocardiograms were collected and analyzed for the following parameters: ECG mean heart rate, PR, QT, QTcB Interval, corrected QT interval using Fidericia's Method (QTcF) Interval, RR Interval and QRS Domain.

Outcome measures

Measure	NMRA-335140 n=102 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=102 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 8 Weeks

Population: Safety Population.

Physical examination included the assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, abdomen (including liver and kidneys), musculoskeletal system, neurological system, gastrointestinal system, genitourinary system, endocrine system and lymph nodes. Abnormality in physical examination were based on investigator's discretion.

Outcome measures

Measure	NMRA-335140 n=102 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=102 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Number of Participants With Clinically Significant Changes in Physical Examinations	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 8 Weeks

Population: Safety Population.

Ophthalmologic examinations were conducted in this study as follows: Standard ophthalmologic examinations: to include best corrected visual acuity assessment, slit-lamp examination of both eyes including assessment of intraocular pressure, as well as dilation of the pupils to examine the optic nerve and retina. Corneal specular microscopy: noncontact or contact specular microscopy for qualitative and quantitative examination of the central corneal endothelium (cell count, cell shape, density, and morphology), with image capture.

Outcome measures

Measure	NMRA-335140 n=102 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=102 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Number of Participants With Clinically Significant Changes in Ophthalmologic Examination Findings	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Week 8

Population: Safety Population who completed C-SSRS at Week 8 has been presented.

A scale to measure suicide thoughts and behavior. Suicidal thoughts are assessed by binary responses (yes/no): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with some intent to act and without specific plan, active suicidal ideation with specific plan and intent, preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide death. A numerical suicidal ideation score is assigned for the first 5 binary items ranging from 0 (no ideation) to 5 (active ideation with plan and intent).

Outcome measures

Measure	NMRA-335140 n=75 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=68 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Number of Participants Reporting Suicidal Behaviors or Ideation As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At Week 8

Population: Safety Population who completed COWS at Week 8 has been presented.

The COWS is a clinician administered instrument used to rate 11 common opiate withdrawal signs or symptoms. The total score of the 11 items was used to assess a participant's level of opiate withdrawal and to determine his/her level of physical dependence on opioids. Scores range from 0 to 48 with higher scores indicating greater severity of opioid withdrawal symptoms. Baseline is defined as the last measurement prior to the start of study drug administration.

Outcome measures

Measure	NMRA-335140 n=75 Participants Participants were randomized in a 1:1 ratio and received 80 milligrams (mg) of NMRA-335140 once daily orally.	Placebo n=62 Participants Participants were randomized in a 1:1 ratio and received matching placebo once daily orally.
Number of Participants Reporting Clinically Significant Response to Clinical Opiate Withdrawal Scale (COWS)	0 Participants	0 Participants

Adverse Events

NMRA-335140

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	NMRA-335140 n=102 participants at risk Participants were randomized in a 1:1 ratio and received NMRA-335140 or Placebo once daily orally.	Placebo n=102 participants at risk Participants were randomized in a 1:1 ratio and received NMRA-335140 or Placebo once daily orally.
Psychiatric disorders Suicide attempt	0.00% 0/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.	0.98% 1/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.

Other adverse events

Measure	NMRA-335140 n=102 participants at risk Participants were randomized in a 1:1 ratio and received NMRA-335140 or Placebo once daily orally.	Placebo n=102 participants at risk Participants were randomized in a 1:1 ratio and received NMRA-335140 or Placebo once daily orally.
Infections and infestations COVID-19	3.9% 4/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.	2.9% 3/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.
Infections and infestations Upper respiratory tract infection	2.9% 3/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.	0.98% 1/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.
Gastrointestinal disorders Nausea	4.9% 5/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.	0.98% 1/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.
Gastrointestinal disorders Diarrhoea	2.0% 2/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.	2.9% 3/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.
Nervous system disorders Headache	4.9% 5/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.	4.9% 5/102 • Up to 8 Weeks TEAEs and SAEs were collected in Safety Population. Safety Population comprised of all participants who received study drug. TEAEs in \>2% participants in each treatment groups have been presented.

Additional Information

Study Contact

Neumora Therapeutics, Inc.

Phone: +1- (857) 760-0900

Email: clinicaltrials@neumoratx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER