A Study of LY3305677 Compared With Placebo in Adult Parti... | NCT06124807

ID	Type	Description	Link
W8M-MC-OXA1	Other Identifier	ISA Number
CWMM Master Protocol	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
3/6 Milligrams (mg) Mazdutide	Experimental	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.	Drug: Mazdutide
10 mg Mazdutide	Experimental	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.	Drug: Mazdutide
16 mg Mazdutide	Experimental	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then16 mg from Weeks 20-48.	Drug: Mazdutide
Placebo	Placebo Comparator	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Mazdutide	Drug	Administered subcutaneous (SC)	10 mg Mazdutide 16 mg Mazdutide 3/6 Milligrams (mg) Mazdutide

Measure	Description	Time Frame
Percent Change From Baseline in Body Weight at Week 32	Least squares means were calculated using an MMRM model for post-baseline measures: Variable = BaselineTime + StrataTime + Treatment*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (<=30, >30 kg/m^2).	Baseline, Week 32

Measure	Description	Time Frame
Percent Change From Baseline in Body Weight at Week 48	Least squares means were calculated using an MMRM model for post-baseline measures: Variable = BaselineTime + StrataTime + Treatment*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (<=30, >30 kg/m^2).	Baseline, Week 48

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa		Chandler	Arizona	85225	United States

Label	URL
A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight	View source

ID	Title	Description
FG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
FG001	3/6 Milligrams (mg) Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 28, 2024	Jan 11, 2026

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

Percent Change From Baseline in Body Weight at Week 32

Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline*Time + Strata*Time + Treatment*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (<=30, >30 kg/m^2).

All randomized participants who were evaluable for this outcome.

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Week 32

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
OG003	16 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.

Units	Counts
Participants	OG00048 OG00132 OG00248 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.85± 0.787 OG001-7.33± 0.937 OG002-15.6± 0.744 OG003

Secondary

Percent Change From Baseline in Body Weight at Week 48

All randomized participants who were evaluable for this outcome.

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Change From Baseline in Body Weight

Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline*Time + Strata*Time + Treatment*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (<=30, >30 kg/m^2).

All randomized participants who were evaluable for this outcome.

Posted

Least Squares Mean

Standard Error

Kilograms (Kg)

Baseline, Week 32, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Mean Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Mean percentage of participants who achieve ≥5% body weight reduction was calculated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.

All randomized participants who were evaluable for this outcome.

Posted

Mean

Standard Error

percentage of participants

Baseline, Week 32, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Mean Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Mean percentage of participants who achieve ≥10% body weight reduction was calculated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.

All randomized participants who were evaluable for this outcome.

Posted

Mean

Standard Error

percentage of participants

Baseline, Week 32, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Change From Baseline in Body Mass Index (BMI)

Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline*Time + Strata*Time + Treatment*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (<=30, >30 kg/m^2).

All randomized participants who were evaluable for this outcome.

Posted

Least Squares Mean

Standard Error

kilogram per square metre (kg/m^2)

Baseline, Week 32, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs)

Blood samples were tested to determine if a participant reacted to Mazdutide by producing anti-Mazdutide antibodies. A participant is TE ADA evaluable if there is at least one non-missing test result for ADA for each of the baseline period and the postbaseline period. A TE ADA evaluable participant is considered to be TE ADA+ if the participant has at least one postbaseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the subject is TE ADA+ if there is at least one postbaseline result of ADA Present with titer >=1:20.

All participants who are exposed to at least one dose of study intervention and had least one non-missing test result for ADA for each of the baseline period and the post-baseline period.

Posted

Count of Participants

Participants

Baseline up to week 56

ID	Title	Description
OG000	Placebo	Participants received matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 Milligrams (mg) Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002

Secondary

Pharmacokinetics (PK): Area Under the Curve (AUC) of Mazdutide at Steady State

PK samples were analyzed using a population PK approach to estimate AUC at steady state. Data presented are Geometric mean with 90% prediction interval.

All randomized participants who had evaluable PK data for this outcome. Per protocol, PK data was pre-specified to be analyzed separately by individual target doses.

Posted

Geometric Mean

90% Confidence Interval

nanogram*hour per milliliter (ng*h/mL)

Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 32, Week 48; Post dose (2 to 6 hours after dosing) at Week 0, Week 12, Week 24

ID	Title	Description
OG000	3 mg Mazdutide	All Participants who received once-weekly subcutaneous 3 mg Mazdutide from Weeks 4-31.
OG001	6 mg Mazdutide	All Participants who received once-weekly subcutaneous 6 mg Mazdutide from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

PK: Maximum Concentration (Cmax) of Mazdutide at Steady State

PK samples were analyzed using a population PK approach to estimate Cmax at steady state. Data presented are Geometric mean with 90% prediction interval.

All randomized participants who had evaluable PK data for this outcome. Per protocol, PK data was pre-specified to be analyzed separately by individual target doses.

Posted

Geometric Mean

90% Confidence Interval

nanogram per milliliter (ng/mL)

Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 32, Week 48; Post dose (2 to 6 hours after dosing) at Week 0, Week 12, Week 24

ID	Title	Description
OG000	3 mg Mazdutide	All Participants who received once-weekly subcutaneous 3 mg Mazdutide from Weeks 4-31.
OG001	6 mg Mazdutide	All Participants who received once-weekly subcutaneous 6 mg Mazdutide from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Change From Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) in Participants With Baseline LFC >=5%

Least squares means were calculated using an MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = Treatment*Time + log(Baseline)*Time + Strata*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (<=30, >30 kg/m^2).

All randomized participants who were evaluable for this outcome.

Posted

Least Squares Mean

Standard Error

Percentage of liver fat content

Baseline, Week 32, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=5%

Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment*Time + log (Baseline)*Time + Strata*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (<=30, >30 kg/m^2).

All randomized participants who were evaluable for this outcome.

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Week 32, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%

Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment*Time + log (Baseline)*Time + Strata*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (<=30, >30 kg/m^2).

All randomized participants who were evaluable for this outcome.

Posted

Least Squares Mean

Standard Error

Percentage of liver fat content

Baseline, Week 32, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%

Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment*Time + log (Baseline)*Time + Strata*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (<=30, >30 kg/m^2).

All randomized participants who were evaluable for this outcome.

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Week 32, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >= 5% Who Achieved >30% Relative Reduction in LFC

mean Percentage of participants with baseline liver fat content (LFC) >= 5% who achieved >30% relative reduction in LFC was estimated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.

All randomized participants who were evaluable for this outcome.

Posted

Mean

Standard Error

percentage of participants

Baseline, Week 32, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Secondary

Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >=10% Who Achieved >30% Relative Reduction in LFC

Mean Percentage of participants with baseline liver fat content (LFC) >=10% who achieved >30% relative reduction in LFC was estimated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.

All randomized participants who were evaluable for this outcome.

Posted

Mean

Standard Error

percentage of participants

Baseline, Week 32, Week 48

ID	Title	Description
OG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
OG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
OG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected47 at risk EG0011 events1 affected32 at risk EG0021 events1 affected47 at risk EG0036 events4 affected51 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected47 at risk EG0011 events1 affected32 at risk EG0024 events4 affected47 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected47 at risk EG0012 events2 affected32 at risk EG0020 events0 affected47 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected47 at risk EG0018 events7 affected32 at risk EG00217 events14 affected47 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0007 events6 affected47 at risk EG00115 events9 affected32 at risk EG00216 events12 affected47 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected47 at risk EG0012 events2 affected32 at risk EG0020 events0 affected47 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected47 at risk EG0012 events2 affected32 at risk EG0026 events5 affected47 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected32 at risk EG0021 events1 affected47 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0013 events3 affected32 at risk EG0022 events2 affected47 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00015 events12 affected47 at risk EG00121 events14 affected32 at risk EG00236 events22 affected47 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0017 events7 affected32 at risk EG0029 events6 affected47 at risk EG003
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG0005 events3 affected47 at risk EG0018 events6 affected32 at risk EG00225 events11 affected47 at risk EG003
Injection site reaction	General disorders	MedDRA 28.0	Systematic Assessment	EG0003 events1 affected47 at risk EG0012 events2 affected32 at risk EG0020 events0 affected47 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0012 events2 affected32 at risk EG0020 events0 affected47 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected32 at risk EG0020 events0 affected47 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected47 at risk EG0013 events3 affected32 at risk EG0022 events2 affected47 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected31 at risk EG0010 events0 affected21 at risk EG0021 events1 affected31 at risk EG003
Covid-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0007 events6 affected47 at risk EG0010 events0 affected32 at risk EG0022 events2 affected47 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0013 events3 affected32 at risk EG0021 events1 affected47 at risk EG003
Gastrointestinal viral infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected32 at risk EG0020 events0 affected47 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected47 at risk EG0011 events1 affected32 at risk EG0022 events2 affected47 at risk EG003
Sinusitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected47 at risk EG0011 events1 affected32 at risk EG0023 events3 affected47 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0008 events7 affected47 at risk EG0017 events6 affected32 at risk EG0027 events7 affected47 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0013 events3 affected32 at risk EG0027 events6 affected47 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected32 at risk EG0020 events0 affected47 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0013 events3 affected32 at risk EG0024 events3 affected47 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected32 at risk EG0021 events1 affected47 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected47 at risk EG0013 events2 affected32 at risk EG0021 events1 affected47 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected32 at risk EG0020 events0 affected47 at risk EG003
Vitamin b12 deficiency	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected32 at risk EG0020 events0 affected47 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected47 at risk EG0015 events4 affected32 at risk EG0021 events1 affected47 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected32 at risk EG0020 events0 affected47 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected11 at risk EG0020 events0 affected16 at risk EG003
Dizziness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected47 at risk EG0012 events2 affected32 at risk EG0023 events3 affected47 at risk EG003
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0006 events5 affected47 at risk EG0014 events4 affected32 at risk EG0025 events4 affected47 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected47 at risk EG0010 events0 affected32 at risk EG0023 events3 affected47 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected47 at risk EG0010 events0 affected32 at risk EG0020 events0 affected47 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected11 at risk EG0020 events0 affected16 at risk EG003
Prostatic mass	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected11 at risk EG0020 events0 affected16 at risk EG003
Prostatomegaly	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected11 at risk EG0020 events0 affected16 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected32 at risk EG0020 events0 affected47 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected32 at risk EG0021 events1 affected47 at risk EG003
Sensitive skin	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected32 at risk EG0023 events3 affected47 at risk EG003
Hypotension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected32 at risk EG0021 events1 affected47 at risk EG003

ID	Term
D009765	Obesity
D050177	Overweight
D015431	Weight Loss
D044343	Overnutrition

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001836	Body Weight Changes

ID	Title	Description
BG000	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
BG001	3/6 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
BG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
BG003	16 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
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	Placebo	Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48	47	1	47	34	47
EG001	3/6 Milligrams (mg) Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.	32	1	32	29	32
EG002	10 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.	47	1	47	37	47
EG003	16 mg Mazdutide	Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.	51	2	51	45	51

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cholecystitis acute	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected32 at risk EG0020 events0 affected47 at risk EG0031 events1 affected51 at risk
Hepatic necrosis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected32 at risk EG0020 events0 affected47 at risk EG003
Dizziness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected32 at risk EG0020 events0 affected47 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected32 at risk EG0021 events1 affected47 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected32 at risk EG0020 events0 affected47 at risk EG003