DRUG
Mazdutide
Administered subcutaneous (SC)
Status
Completed
Phase
Phase 2
Enrollment
179
Locations
29
Results
Posted
Publications
0
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.
Interventions
DRUG
Administered subcutaneous (SC)
DRUG
Administered SC
Timeline
First posted
Nov 9, 2023
Study start
Nov 17, 2023
Primary completion
Jan 22, 2025
Study completion
Jul 9, 2025
Results posted
Apr 21, 2026
Registry updated
Apr 21, 2026
Outcomes
Percent Change From Baseline in Body Weight at Week 32
Time frame · Baseline, 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).
Percent Change From Baseline in Body Weight at Week 48
Time frame · Baseline, 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).
Change From Baseline in Body Weight
Time frame · Baseline, Week 32, 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 (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Mean Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Time frame · Baseline, Week 32, Week 48
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.
Mean Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time frame · Baseline, Week 32, Week 48
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.
Change From Baseline in Body Mass Index (BMI)
Time frame · Baseline, Week 32, 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 (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs)
Time frame · Baseline up to week 56
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.
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mazdutide at Steady State
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
PK samples were analyzed using a population PK approach to estimate AUC at steady state. Data presented are Geometric mean with 90% prediction interval.
PK: Maximum Concentration (Cmax) of Mazdutide at Steady State
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
PK samples were analyzed using a population PK approach to estimate Cmax at steady state. Data presented are Geometric mean with 90% prediction interval.
Change From Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) in Participants With Baseline LFC >=5%
Time frame · Baseline, Week 32, Week 48
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).
Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=5%
Time frame · Baseline, Week 32, Week 48
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).
Eligibility
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: 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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Charter Research - Winter Park
Orlando, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Knownwell
Needham, Massachusetts, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Dent Neurologic Institute
Amherst, New York, United States
North Suffolk Neurology
Port Jefferson Station, New York, United States
Lucas Research, Inc.
New Bern, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Quality Medical Research
Nashville, Tennessee, United States
IMA Clinical Research Austin
Austin, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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