Study to Evaluate the Safety and Efficacy of Teropavimab... | NCT04811040

Label	Type	Description	Intervention Names
Primary Cohort: Lenacapavir (LEN) + Teropavimab + Zinlirvimab 10 mg/kg	Experimental	Participants will receive a loading dose of 600 milligrams (mg) LEN orally on Day 1 and Day 2, along with 927 mg LEN as subcutaneous (SC) injection on Day 1. Thereafter, participants will receive 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an intravenous (IV) infusion on Day 1.	Drug: Oral Lenacapavir Drug: Subcutaneous Lenacapavir Drug: Teropavimab Drug: Zinlirvimab
Primary Cohort: LEN + Teropavimab + Zinlirvimab 30 mg/kg	Experimental	Participants will receive a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants will receive 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.	Drug: Oral Lenacapavir Drug: Subcutaneous Lenacapavir Drug: Teropavimab Drug: Zinlirvimab
Pilot Cohort: LEN +Teropavimab +Zinlirvimab 10 mg/kg	Experimental	Participants will receive a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants will receive 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.	Drug: Oral Lenacapavir Drug: Subcutaneous Lenacapavir Drug: Teropavimab Drug: Zinlirvimab
Pilot Cohort: LEN +Teropavimab +Zinlirvimab 30 mg/kg	Experimental	Participants will receive a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants will receive 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Name	Type	Description	Arm Group Labels	Other Names
Oral Lenacapavir	Drug	Tablets administered without regard to food	Pilot Cohort: LEN +Teropavimab +Zinlirvimab 10 mg/kg Pilot Cohort: LEN +Teropavimab +Zinlirvimab 30 mg/kg

Measure	Description	Time Frame
Primary Cohort: Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)	A treatment emergent SAE was defined as an event that, at any dose, resulted in the following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; a medically important event or reaction: such events may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes constituting SAEs. These events had an onset date on or after the study drug start date and prior to the last exposure date of long-acting (LA) regimen period for the LA regimen period analysis. The long acting regimen period included participants who were randomized and received at least one dose of the complete LA study drug regimen (ie, SC LEN + Teropavimab + Zinlirvimab).	Day 1 up to Week 26

Measure	Description	Time Frame
Primary Cohort: Percentage of Participants With Human Immunodeficiency Virus- 1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 26 as Determined by the US Food and Drug Administration (FDA)-Defined Snapshot Algorithm	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 26 was analyzed using the snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 26 analysis window. Week 26 window was between Days 176 and 224 (inclusive).

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Ruane Clinical Research Group Inc.		Los Angeles	California	90036	United States
Mills Clinical Research

PubMed Identifier	Type	Citation
	Background	Eron JJ, Cook PP, Mehrotra ML, Huang H, Caskey M, Crofoot GE, DeJesus E, Gorgos L, VanderVeen LA, Osiyemi OO, Brinson C, Collins SE. Lenacapavir Plus bNAbs for People with HIV and Susceptibility to Either Teropavimab or Zinlirvimab [Oral]. Conference on Retroviruses and Opportunistic Infections (CROI); 2024 3-6 March, Denver, CO.
38307098	Background	Eron JJ, Little SJ, Crofoot G, Cook P, Ruane PJ, Jayaweera D, VanderVeen LA, DeJesus E, Zheng Y, Mills A, Huang H, Waldman SE, Ramgopal M, Gorgos L, Collins SE, Baeten JM, Caskey M. Safety of teropavimab and zinlirvimab with lenacapavir once every 6 months for HIV treatment: a phase 1b, randomised, proof-of-concept study. Lancet HIV. 2024 Mar;11(3):e146-e155. doi: 10.1016/S2352-3018(23)00293-X. Epub 2024 Jan 30.
	Background	Eron J, Little SJ, Crofoot G, Cook P, Ruane PJ, Jayaweera D, DeJesus E, Walkman SE, Mehrotra ML, VanderVeen L, Huang H, Collins S, Baeten J, Caskey M. Lenacapavir with bNAbs Teropavimab (GS-5423) and Zinlirvimab (GS-2872) Dosed Every 6 Months in People with HIV [Oral 193]. Conference on Retroviruses and Opportunistic Infections (CROI); 2023 19-22 February, Seattle, WA

Label	URL
Gilead Clinical Trials Website	View source

ID	Title	Description
FG000	Primary Cohort: Lenacapavir (LEN)+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 milligram (mg) LEN orally on Day 1 and Day 2, along with 927 mg LEN as subcutaneous (SC) injection on Day 1. Thereafter, participants received 30 milligram per kilogram (mg/kg) teropavimab and then 10 mg/kg zinlirvimab as an intravenous (IV) infusion on Day 1.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 30, 2022	Sep 3, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Primary Cohort: Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)

A treatment emergent SAE was defined as an event that, at any dose, resulted in the following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; a medically important event or reaction: such events may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes constituting SAEs. These events had an onset date on or after the study drug start date and prior to the last exposure date of long-acting (LA) regimen period for the LA regimen period analysis. The long acting regimen period included participants who were randomized and received at least one dose of the complete LA study drug regimen (ie, SC LEN + Teropavimab + Zinlirvimab).

The Safety Analysis Set for the LA regimen included all randomized participants who had received at least 1 dose of the complete LA study drug regimen (ie, SC LEN + Teropavimab + Zinlirvimab).

Posted

Number

percentage of participants

Day 1 up to Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants	OG00010 OG00110

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

Secondary

Primary Cohort: Percentage of Participants With Human Immunodeficiency Virus- 1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 26 as Determined by the US Food and Drug Administration (FDA)-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 26 was analyzed using the snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 26 analysis window. Week 26 window was between Days 176 and 224 (inclusive).

The Full Analysis Set included all randomized participants who had received at least 1 dose of the complete LA study drug regimen (ie, SC LEN + Teropavimab + Zinlirvimab) without major protocol violation (defined as meeting exclusion criterion of having chronic hepatitis B virus infection).

Posted

Number

95% Confidence Interval

percentage of participants

Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Secondary

Primary Cohort: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using the snapshot algorithm, which defined a participant's virologic outcome and included participants a) who had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to AE or death and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL.

Week 26 window was between Days 176 and 224 (inclusive).

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg

Secondary

Primary Cohort: Percentage of Participants With Positive Anti-Teropavimab Antibodies

Anti-teropavimab antibodies positive participants are participants with positive treatment-emergent anti-drug antibody.

Anti-teropavimab Immunogenicity Analysis Set included all randomized participants who had received at least 1 dose of study drug and have had at least 1 nonmissing value for anti-teropavimab evaluation.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: Percentage of Participants With Positive Anti-zinlirvimab Antibodies

Anti-zinlirvimab antibodies positive participants are participants with positive treatment-emergent anti-drug antibody.

Anti-zinlirvimab Immunogenicity Analysis Set included all randomized participants who had received at least 1 dose of study drug and have had at least 1 nonmissing value for anti- zinlirvimab evaluation.

Posted

Number

percentage of participants

Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 26

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

cells per microliter (cells/µL)

Baseline; Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants	OG000

Secondary

Primary Cohort: Number of Participants Who Develop Treatment-Emergent Resistance to LEN, Teropavimab, and Zinlirvimab

Participants in the Resistance Analysis Population analyzed for this outcome included any participant who had received 1 dose of study drug, maintained their study drug regimen, and met one of the following virologic failure criteria:

Participants with HIV-1 RNA >/= 200 copies/mL on 2 consecutive visits
Participants with HIV-1 RNA >/= 200 copies/mL at study discontinuation or Week 26.

Participants in the Resistance Analysis Population included those who experienced virologic failure through Week 26.

Posted

Count of Participants

Participants

Day 1 up to Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants were administered 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab intravenously on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants were administered 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab intravenously on Day 1.

Secondary

Primary Cohort: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

TEAEs were those adverse events that began on or after the first dose date of study drug and prior to last exposure date of LA regimen from participants who prematurely discontinued study or completed study, or any adverse events led to premature study drug discontinuation.

Participants in the Safety Analysis Set for the LA regimen were analyzed.

Posted

Number

percentage of participants

Day 1 up to Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts

Secondary

Primary Cohort: Pharmacokinetic (PK) Parameter: AUC0-26 of Teropavimab

AUC0-26 is defined as the concentration of drug over time from Week zero to Week 26.

The Teropavimab PK Analysis Set included all randomized participants who had received at least 1 dose of study drug, and had at least 1 nonmissing teropavimab concentration value reported by the PK laboratory test.

Posted

Mean

Standard Deviation

day* μg/mL

Predose and at End of Infusion (EOI) of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts

Secondary

Primary Cohort: PK Parameter: AUC0-26 of Zinlirvimab

AUC0-26 is defined as the concentration of drug over time from Week zero to Week 26.

The Zinlirvimab PK Analysis Set included all randomized participants who had received at least 1 dose of study drug, and had at least 1 nonmissing zinlirvimab concentration value reported by the PK laboratory test. Participants with available data were analyzed.

Posted

Mean

Standard Deviation

day* μg/mL

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts

Secondary

Primary Cohort: PK Parameter: AUClast of Teropavimab

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Participants in the Teropavimab PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

day* μg/mL

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: AUClast of Zinlirvimab

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Participants in the Zinlirvimab PK Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

day* μg/mL

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants were administered 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab intravenously on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants were administered 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab intravenously on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: T1/2 of LEN

T1/2 is defined as the estimate of the terminal elimination half-life of the drug.

The LEN PK Analysis Set included all randomized participants who had received at least 1 dose of study drug, and had at least 1 nonmissing LEN concentration value reported by the PK laboratory test. Participants with available data were analyzed.

Posted

Median

Full Range

day

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts

Secondary

Primary Cohort: PK Parameter: T1/2 of Teropavimab

T1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Participants in the Teropavimab PK Analysis Set were analyzed.

Posted

Median

Full Range

day

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: T1/2 of Zinlirvimab

T1/2 is defined as the estimate of the terminal elimination half-life of the drug.

Participants in the Zinlirvimab PK Analysis Set with available data were analyzed.

Posted

Median

Full Range

day

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: Cmax of Teropavimab

Cmax is defined as the maximum observed concentration of drug.

Participants in the Teropavimab PK Analysis Set were analyzed.

Posted

Mean

Standard Deviation

μg/mL

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: Cmax of Zinlirvimab

Cmax is defined as the maximum observed concentration of drug.

Participants in the Zinlirvimab PK Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

μg/mL

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: Tmax of Teropavimab

Tmax is defined as the time (observed time point) of Cmax.

Participants in the Teropavimab PK Analysis Set were analyzed.

Posted

Median

Full Range

hours

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: Tmax of Zinlirvimab

Tmax is defined as the time (observed time point) of Cmax.

Participants in the Zinlirvimab PK Analysis Set with available data were analyzed.

Posted

Median

Full Range

hours

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: Tlast of LEN

Tlast is defined as the time (observed time point) of Clast (the last observable concentration of drug).

Participants in the LEN PK Analysis Set were analyzed.

Posted

Median

Full Range

day

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants were administered 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab intravenously on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants were administered 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab intravenously on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: Tlast of Teropavimab

Tlast is defined as the time (observed time point) of Clast (the last observable concentration of drug).

Participants in the Teropavimab PK Analysis Set were analyzed.

Posted

Median

Full Range

day

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: Tlast of Zinlirvimab

Tlast is defined as the time (observed time point) of Clast (the last observable concentration of drug).

Participants in the Zinlirvimab PK Analysis Set were analyzed.

Posted

Median

Full Range

day

Predose and at EOI of teropavimab and zinlirvimab on Day 1; Weeks 4, 8, 12, 16, 20, 24, 26, 38, 52, up to end of study (up to Week 55)

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants

Secondary

Primary Cohort: PK Parameter: C26week of LEN

C26week is the concentration at week 26.

Participants in the LEN PK Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

ng/mL

Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants	OG000

Secondary

Primary Cohort: PK Parameter: C26week of Teropavimab

C26week is the concentration at week 26.

Participants in the Teropavimab PK Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

μg/mL

Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants	OG000

Secondary

Primary Cohort: PK Parameter: C26week of Zinlirvimab

C26week is the concentration at week 26.

Participants in the Zinlirvimab PK Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

μg/mL

Week 26

ID	Title	Description
OG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
OG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0012 affected10 at risk EG0020 affected5 at risk EG0030 affected6 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0021 affected5 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Abnormal faeces	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Glossitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0021 affected5 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Chills	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0021 affected5 at risk EG003
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Influenza like illness	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Injection site bruising	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Injection site discolouration	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Injection site erythema	General disorders	MedDRA 26.1	Systematic Assessment	EG0004 affected11 at risk EG0013 affected10 at risk EG0020 affected5 at risk EG003
Injection site induration	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected11 at risk EG0014 affected10 at risk EG0020 affected5 at risk EG003
Injection site inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Injection site mass	General disorders	MedDRA 26.1	Systematic Assessment	EG0003 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Injection site nodule	General disorders	MedDRA 26.1	Systematic Assessment	EG0004 affected11 at risk EG0012 affected10 at risk EG0021 affected5 at risk EG003
Injection site oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Injection site pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0005 affected11 at risk EG0015 affected10 at risk EG0020 affected5 at risk EG003
Injection site paraesthesia	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Injection site pruritus	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Injection site reaction	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Peripheral swelling	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Bacterial vulvovaginitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Covid-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 affected11 at risk EG0011 affected10 at risk EG0021 affected5 at risk EG003
Diabetic foot infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Escherichia infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Folliculitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Gastroenteritis Escherichia coli	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Genital herpes	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Gonorrhoea	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0021 affected5 at risk EG003
Hordeolum	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Injection site cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Oral herpes	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Oropharyngeal gonococcal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Pharyngeal chlamydia infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Rhinitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Secondary syphilis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0021 affected5 at risk EG003
Shigella infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Syphilis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Varicella zoster virus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Urine analysis abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0021 affected5 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0012 affected10 at risk EG0020 affected5 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Myokymia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Migraine	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Tension headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0012 affected10 at risk EG0020 affected5 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Bladder discomfort	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Genital lesion	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Lower respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0012 affected10 at risk EG0020 affected5 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0011 affected10 at risk EG0020 affected5 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003

ID	Title	Description
BG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
BG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
BG002	Pilot Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.
BG003	Pilot Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.	11	2	11	9	11
EG001	Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.	10	0	10	10	10
EG002	Pilot Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 10 mg/kg zinlirvimab as an IV infusion on Day 1.	5	1	5	4	5
EG003	Pilot Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg	Participants received a loading dose of 600 mg LEN orally on Day 1 and Day 2, along with 927 mg LEN as SC injection on Day 1. Thereafter, participants received 30 mg/kg teropavimab and then 30 mg/kg zinlirvimab as an IV infusion on Day 1.	6	0	6	5	6

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG0030 affected6 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 affected11 at risk EG0010 affected10 at risk EG0020 affected5 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected11 at risk EG0010 affected10 at risk EG0021 affected5 at risk EG003