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CompletedNCT06124807Updated Apr 21, 2026Results posted

A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

A Phase 2 interventional study of Mazdutide and Placebo in Obesity and Overweight and Obesity, sponsored by Eli Lilly and Company. Completed at 29 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
179
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The main purpose of this study, performed under a master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with Mazdutide compared with placebo and in adult participants with obesity or overweight. The study will last about 62 weeks.

02

Conditions studied

  • Obesity
  • Overweight and Obesity

Keywords

  • Incretins
  • Weight Loss
  • Overnutrition
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

W8M-MC-OXA1:

  • Are males and females who agree to abide by the reproductive and contraceptive requirements

W8M-MC-CWMM:

  • Have a BMI ≥27 kilograms per square meter (kg/m²)

Exclusion criteria

Exclusion Criteria:

W8M-MC-OXA1:

  • Have any prior diagnosis of diabetes mellitus, that is type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus, except gestational diabetes.

  • Have any of the following cardiovascular conditions within 6 months prior to screening:

    • acute myocardial infarction
    • cerebrovascular accident (stroke)
    • unstable angina, or
    • hospitalization due to congestive heart failure (CHF).
  • Have a history of New York Heart Association (NYHA) Functional Classification I-IV CHF.
  • Participants with hypertension who do not have well-controlled blood pressure (BP) (>140/90 mmHg), regardless of antihypertensive treatment. Participants receiving treatment for hypertension should be on a stable antihypertensive regimen for at least 3 months prior to screening.
  • Have a history of acute or chronic pancreatitis.

Note: If the investigator anticipates a need to add antihypertensive medication during the study, the participant should not be included in the ambulatory blood pressure monitoring (ABPM) procedures.

CWMM:

  • Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening.
  • Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
  • Have poorly controlled hypertension.
  • Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
  • Have a history of symptomatic gallbladder disease within the past 2 years.
  • Have a lifetime history of suicide attempts.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
179 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Mazdutide

  • Experimental
    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.

    Drug: Mazdutide

  • Experimental
    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 then16 mg from Weeks 20-48.

    Drug: Mazdutide

  • Placebo comparator
    Placebo

    Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.

    Drug: Placebo

Interventions

  • DrugMazdutide

    Administered subcutaneous (SC)

    Also known as: LY3305677

  • DrugPlacebo

    Administered SC

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, Week 32

Secondary outcomes

  1. Percent Change From Baseline in Body Weight at Week 48

    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).

    Time frame: Baseline, Week 48

  2. 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).

    Time frame: Baseline, Week 32, Week 48

  3. 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.

    Time frame: Baseline, Week 32, Week 48

  4. 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.

    Time frame: Baseline, Week 32, Week 48

  5. 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).

    Time frame: Baseline, Week 32, Week 48

  6. 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.

    Time frame: Baseline up to week 56

  7. 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.

    Time frame: 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

  8. 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.

    Time frame: 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

  9. 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).

    Time frame: Baseline, Week 32, Week 48

  10. 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).

    Time frame: Baseline, Week 32, Week 48

  11. 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).

    Time frame: Baseline, Week 32, Week 48

  12. 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).

    Time frame: Baseline, Week 32, Week 48

  13. 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.

    Time frame: Baseline, Week 32, Week 48

  14. 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.

    Time frame: Baseline, Week 32, Week 48

06

Results

Posted Apr 21, 2026

Participant flow

Participant flow — Overall Study
MilestonePlacebo3/6 Milligrams (mg) Mazdutide10 mg Mazdutide16 mg Mazdutide
Started48324851
Safety population (participants who are exposed to at least one dose of study intervention)47324751
Completed29283734
Not completed1941117
Withdrew: Adverse event1025
Withdrew: Lost to follow-up5313
Withdrew: Inadvertent enrollment1010
Withdrew: Met early discontinuation criteria0001
Withdrew: Withdrawal by subject9144
Withdrew: Schedule conflict1000
Withdrew: Did not return for the scheduled safety follow-up2034

Outcome measures

PrimaryPercent 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).

Time frame:
Baseline, Week 32
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Body Weight at Week 32
percent changePlacebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Percent Change From Baseline in Body Weight at Week 32-0.85 ± 0.787-7.33 ± 0.937-15.6 ± 0.744-18.1 ± 0.965
SecondaryPercent Change From Baseline in Body Weight at Week 48

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).

Time frame:
Baseline, Week 48
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Body Weight at Week 48
percent changePlacebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Percent Change From Baseline in Body Weight at Week 48-0.047 ± 1.059-10.54 ± 1.498-19.2 ± 1.076-22.3 ± 1.424
SecondaryChange 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).

Time frame:
Baseline, Week 32, Week 48
Reported as:
Least squares mean · Kilograms (Kg)
Change From Baseline in Body Weight
Kilograms (Kg)Placebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Week 32-0.98 ± 0.882-7.79 ± 1.011-16.1 ± 0.779-19.2 ± 1.037
Week 48-0.15 ± 1.195-11.15 ± 1.601-19.7 ± 1.127-23.9 ± 1.542
SecondaryMean 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.

Time frame:
Baseline, Week 32, Week 48
Reported as:
Mean · percentage of participants
Mean Percentage of Participants Who Achieve ≥5% Body Weight Reduction
percentage of participantsPlacebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Week 3223.97 ± 6.9967.64 ± 8.7096.10 ± 3.5792.23 ± 4.30
Week 4825.96 ± 7.1374.77 ± 8.2795.91 ± 3.4691.90 ± 4.95
SecondaryMean 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.

Time frame:
Baseline, Week 32, Week 48
Reported as:
Mean · percentage of participants
Mean Percentage of Participants Who Achieve ≥10% Body Weight Reduction
percentage of participantsPlacebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Week 328.73 ± 4.5345.43 ± 9.1885.95 ± 5.6777.08 ± 6.45
Week 4813.77 ± 5.8157.86 ± 9.1483.97 ± 5.7080.73 ± 6.43
SecondaryChange 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).

Time frame:
Baseline, Week 32, Week 48
Reported as:
Least squares mean · kilogram per square metre (kg/m^2)
Change From Baseline in Body Mass Index (BMI)
kilogram per square metre (kg/m^2)Placebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Week 32-0.32 ± 0.305-2.84 ± 0.376-5.81 ± 0.281-6.86 ± 0.372
Week 48-0.017 ± 0.430-4.07 ± 0.609-7.15 ± 0.409-8.53 ± 0.559
SecondaryNumber 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.

Time frame:
Baseline up to week 56
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs)
ParticipantsPlacebo3/6 Milligrams (mg) Mazdutide10 mg Mazdutide16 mg Mazdutide
Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs)531011
SecondaryPharmacokinetics (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.

Time frame:
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
Reported as:
Geometric mean · nanogram*hour per milliliter (ng*h/mL)
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mazdutide at Steady State
nanogram*hour per milliliter (ng*h/mL)3 mg Mazdutide6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mazdutide at Steady State93800 (44800 to 199000)190000 (90600 to 404000)340000 (158000 to 758000)537000 (240000 to 1210000)
SecondaryPK: 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.

Time frame:
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
Reported as:
Geometric mean · nanogram per milliliter (ng/mL)
PK: Maximum Concentration (Cmax) of Mazdutide at Steady State
nanogram per milliliter (ng/mL)3 mg Mazdutide6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
PK: Maximum Concentration (Cmax) of Mazdutide at Steady State694 (356 to 1330)1420 (735 to 2880)2530 (1290 to 5380)4020 (2000 to 8020)
SecondaryChange 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).

Time frame:
Baseline, Week 32, Week 48
Reported as:
Least squares mean · Percentage of liver fat content
Change From Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) in Participants With Baseline LFC >=5%
Percentage of liver fat contentPlacebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Week 32-1.62 ± 0.770-6.15 ± 0.615-7.78 ± 0.462-7.91 ± 0.548
Week 48-1.35 ± 0.872-7.81 ± 0.444-8.07 ± 0.448-7.74 ± 0.670
SecondaryPercent 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).

Time frame:
Baseline, Week 32, Week 48
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=5%
percent changePlacebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Week 32-14.1 ± 6.70-53.5 ± 5.35-67.7 ± 4.02-68.8 ± 4.76
Week 48-11.7 ± 7.58-68.0 ± 3.86-70.2 ± 3.90-67.4 ± 5.83
SecondaryChange 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).

Time frame:
Baseline, Week 32, Week 48
Reported as:
Least squares mean · Percentage of liver fat content
Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%
Percentage of liver fat contentPlacebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Week 32-4.3 ± 1.48-9.3 ± 1.43-13.8 ± 0.49-12.8 ± 1.06
Week 48-4.6 ± 1.67-12.4 ± 0.95-13.9 ± 0.62-12.6 ± 1.40
SecondaryPercent 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).

Time frame:
Baseline, Week 32, Week 48
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%
percent changePlacebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Week 32-24.7 ± 8.51-53.4 ± 8.26-79.5 ± 2.80-73.6 ± 6.08
Week 48-26.3 ± 9.63-71.2 ± 5.45-80.2 ± 3.55-72.3 ± 8.09
SecondaryMean 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.

Time frame:
Baseline, Week 32, Week 48
Reported as:
Mean · percentage of participants
Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >= 5% Who Achieved >30% Relative Reduction in LFC
percentage of participantsPlacebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Week 3224.93 ± 8.6773.97 ± 10.2984.93 ± 6.3983.40 ± 7.41
Week 4830.04 ± 9.1687.73 ± 8.5885.70 ± 7.1984.23 ± 8.82
SecondaryMean 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.

Time frame:
Baseline, Week 32, Week 48
Reported as:
Mean · percentage of participants
Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >=10% Who Achieved >30% Relative Reduction in LFC
percentage of participantsPlacebo3/6 mg Mazdutide10 mg Mazdutide16 mg Mazdutide
Week 3238.57 ± 12.9871.95 ± 14.1399.71 ± 1.9292.04 ± 7.73
Week 4836.82 ± 13.3686.64 ± 10.8890.46 ± 7.9378.36 ± 12.46

Adverse events

Collected over Baseline up to Week 56. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/47 (0%)1/47 (2.1%)34/47 (72.3%)
3/6 Milligrams (mg) Mazdutide0/32 (0%)1/32 (3.1%)29/32 (90.6%)
10 mg Mazdutide0/47 (0%)1/47 (2.1%)37/47 (78.7%)
16 mg Mazdutide0/51 (0%)2/51 (3.9%)45/51 (88.2%)
Most frequent serious events
Most frequent serious events
EventPlacebo3/6 Milligrams (mg) Mazdutide10 mg Mazdutide16 mg Mazdutide
NephrolithiasisRenal and urinary disorders0/471/320/470/51
Hepatic necrosisHepatobiliary disorders1/470/320/470/51
EpilepsyNervous system disorders0/470/321/470/51
Cholecystitis acuteHepatobiliary disorders0/470/320/471/51
DizzinessNervous system disorders0/470/320/471/51
Most frequent other events
Showing 10 of 44
Most frequent other events
EventPlacebo3/6 Milligrams (mg) Mazdutide10 mg Mazdutide16 mg Mazdutide
NauseaGastrointestinal disorders12/4714/3222/4734/51
VomitingGastrointestinal disorders1/477/326/4724/51
ConstipationGastrointestinal disorders5/477/3214/4719/51
DiarrhoeaGastrointestinal disorders6/479/3212/4713/51
FatigueGeneral disorders3/476/3211/4713/51
Upper respiratory tract infectionInfections and infestations7/476/327/476/51
DizzinessNervous system disorders3/472/323/479/51
Covid-19Infections and infestations6/470/322/478/51
Urinary tract infectionInfections and infestations1/473/326/474/51
ArthralgiaMusculoskeletal and connective tissue disorders3/474/321/474/51

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)Placebo3/6 mg Mazdutide10 mg Mazdutide16 mg MazdutideTotal
Mean45.7 ± 12.548.6 ± 13.848.4 ± 10.148.3 ± 13.347.7 ± 12.3
Sex: Female, Male
Sex: Female, Male(Participants)Placebo3/6 mg Mazdutide10 mg Mazdutide16 mg MazdutideTotal
Female32213233118
Male1611161861
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo3/6 mg Mazdutide10 mg Mazdutide16 mg MazdutideTotal
Hispanic or Latino14971141
Not Hispanic or Latino34234038135
Unknown or Not Reported00123
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo3/6 mg Mazdutide10 mg Mazdutide16 mg MazdutideTotal
American Indian or Alaska Native00101
Asian23229
Native Hawaiian or Other Pacific Islander00000
Black or African American9711734
White34203338125
More than one race30126
Unknown or Not Reported02024
Region of Enrollment
Region of Enrollment(Participants)Placebo3/6 mg Mazdutide10 mg Mazdutide16 mg MazdutideTotal
United States48324851179
Body Weight
Body Weight(Kilograms (Kg))Placebo3/6 mg Mazdutide10 mg Mazdutide16 mg MazdutideTotal
Mean103.1 ± 21.20109.8 ± 17.71108.5 ± 21.70109.7 ± 20.67107.6 ± 20.63
07

Study locations

29 sites
  • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
    Chandler, Arizona 85225, United States
  • Headlands Research - Scottsdale
    Scottsdale, Arizona 85260, United States
  • The Institute for Liver Health II dba Arizona Liver Health-Tucson
    Tucson, Arizona 85712, United States
  • Velocity Clinical Research, Huntington Park
    Huntington Park, California 90255, United States
  • Peninsula Research Associates
    Rolling Hills Estates, California 90274, United States
  • Diablo Clinical Research, Inc.
    Walnut Creek, California 94598, United States
  • Northeast Research Institute (NERI)
    Fleming Island, Florida 32003, United States
  • Suncoast Clinical Research, Inc.
    New Port Richey, Florida 34652, United States
  • Charter Research - Winter Park
    Orlando, Florida 32803, United States
  • Charter Research - Lady Lake
    The Villages, Florida 32162, United States
  • Pacific Diabetes & Endocrine Center
    Honolulu, Hawaii 96817, United States
  • Great Lakes Clinical Trials - Andersonville
    Chicago, Illinois 60640, United States
  • Great Lakes Clinical Trials - Ravenswood
    Chicago, Illinois 60640, United States
  • Cotton O'Neil Diabetes & Endocrinology
    Topeka, Kansas 66606, United States
  • L-MARC Research Center
    Louisville, Kentucky 40213, United States
  • Knownwell
    Needham, Massachusetts 02492, United States
  • StudyMetrix Research
    City of Saint Peters, Missouri 63303, United States
  • Las Vegas Medical Research
    Las Vegas, Nevada 89128, United States
  • Dent Neurologic Institute
    Amherst, New York 14226, United States
  • North Suffolk Neurology
    Port Jefferson Station, New York 11776, United States
  • Lucas Research, Inc.
    New Bern, North Carolina 28562, United States
  • CTI Clinical Research Center
    Cincinnati, Ohio 45212, United States
  • Quality Medical Research
    Nashville, Tennessee 37211, United States
  • IMA Clinical Research Austin
    Austin, Texas 78745, United States
  • Velocity Clinical Research, Dallas
    Dallas, Texas 75230, United States
  • PlanIt Research, PLLC
    Houston, Texas 77079, United States
  • Tekton Research - Fredericksburg Road
    San Antonio, Texas 78229, United States
  • Spectrum Medical, Inc.
    Danville, Virginia 24541, United States
  • Central Washington Health Services Association d/b/a Confluence Health
    Wenatchee, Washington 98801, United States
08

References and documents

Study documents

  • Study protocol · Oct 28, 2024
  • Statistical analysis plan · May 30, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

09

Registry details

Key details

Study ID
NCT06124807
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 9, 2023
Start date
Nov 17, 2023
Primary completion
Jan 22, 2025
Completion
Jul 9, 2025
Results posted
Apr 21, 2026
Last update
Apr 21, 2026

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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