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
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 179 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
W8M-MC-OXA1:
W8M-MC-CWMM:
Exclusion Criteria:
W8M-MC-OXA1:
Have any of the following cardiovascular conditions within 6 months prior to screening:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
Drug: Placebo
Administered subcutaneous (SC)
Also known as: LY3305677
Administered SC
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Placebo | 3/6 Milligrams (mg) Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide |
|---|---|---|---|---|
| Started | 48 | 32 | 48 | 51 |
| Safety population (participants who are exposed to at least one dose of study intervention) | 47 | 32 | 47 | 51 |
| Completed | 29 | 28 | 37 | 34 |
| Not completed | 19 | 4 | 11 | 17 |
| Withdrew: Adverse event | 1 | 0 | 2 | 5 |
| Withdrew: Lost to follow-up | 5 | 3 | 1 | 3 |
| Withdrew: Inadvertent enrollment | 1 | 0 | 1 | 0 |
| Withdrew: Met early discontinuation criteria | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 9 | 1 | 4 | 4 |
| Withdrew: Schedule conflict | 1 | 0 | 0 | 0 |
| Withdrew: Did not return for the scheduled safety follow-up | 2 | 0 | 3 | 4 |
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 | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 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 |
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 | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 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 |
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).
| Kilograms (Kg) | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 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 |
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.
| percentage of participants | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide |
|---|---|---|---|---|
| Week 32 | 23.97 ± 6.99 | 67.64 ± 8.70 | 96.10 ± 3.57 | 92.23 ± 4.30 |
| Week 48 | 25.96 ± 7.13 | 74.77 ± 8.27 | 95.91 ± 3.46 | 91.90 ± 4.95 |
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.
| percentage of participants | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide |
|---|---|---|---|---|
| Week 32 | 8.73 ± 4.53 | 45.43 ± 9.18 | 85.95 ± 5.67 | 77.08 ± 6.45 |
| Week 48 | 13.77 ± 5.81 | 57.86 ± 9.14 | 83.97 ± 5.70 | 80.73 ± 6.43 |
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).
| kilogram per square metre (kg/m^2) | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 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 |
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.
| Participants | Placebo | 3/6 Milligrams (mg) Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide |
|---|---|---|---|---|
| Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs) | 5 | 3 | 10 | 11 |
PK samples were analyzed using a population PK approach to estimate AUC at steady state. Data presented are Geometric mean with 90% prediction interval.
| nanogram*hour per milliliter (ng*h/mL) | 3 mg Mazdutide | 6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide |
|---|---|---|---|---|
| Pharmacokinetics (PK): Area Under the Curve (AUC) of Mazdutide at Steady State | 93800 (44800 to 199000) | 190000 (90600 to 404000) | 340000 (158000 to 758000) | 537000 (240000 to 1210000) |
PK samples were analyzed using a population PK approach to estimate Cmax at steady state. Data presented are Geometric mean with 90% prediction interval.
| nanogram per milliliter (ng/mL) | 3 mg Mazdutide | 6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide |
|---|---|---|---|---|
| PK: Maximum Concentration (Cmax) of Mazdutide at Steady State | 694 (356 to 1330) | 1420 (735 to 2880) | 2530 (1290 to 5380) | 4020 (2000 to 8020) |
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).
| Percentage of liver fat content | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 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 |
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 | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 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 |
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).
| Percentage of liver fat content | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 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 |
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 | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 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 |
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.
| percentage of participants | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide |
|---|---|---|---|---|
| Week 32 | 24.93 ± 8.67 | 73.97 ± 10.29 | 84.93 ± 6.39 | 83.40 ± 7.41 |
| Week 48 | 30.04 ± 9.16 | 87.73 ± 8.58 | 85.70 ± 7.19 | 84.23 ± 8.82 |
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.
| percentage of participants | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide |
|---|---|---|---|---|
| Week 32 | 38.57 ± 12.98 | 71.95 ± 14.13 | 99.71 ± 1.92 | 92.04 ± 7.73 |
| Week 48 | 36.82 ± 13.36 | 86.64 ± 10.88 | 90.46 ± 7.93 | 78.36 ± 12.46 |
Collected over Baseline up to Week 56. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/47 (0%) | 1/47 (2.1%) | 34/47 (72.3%) |
| 3/6 Milligrams (mg) Mazdutide | 0/32 (0%) | 1/32 (3.1%) | 29/32 (90.6%) |
| 10 mg Mazdutide | 0/47 (0%) | 1/47 (2.1%) | 37/47 (78.7%) |
| 16 mg Mazdutide | 0/51 (0%) | 2/51 (3.9%) | 45/51 (88.2%) |
| Event | Placebo | 3/6 Milligrams (mg) Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide |
|---|---|---|---|---|
| NephrolithiasisRenal and urinary disorders | 0/47 | 1/32 | 0/47 | 0/51 |
| Hepatic necrosisHepatobiliary disorders | 1/47 | 0/32 | 0/47 | 0/51 |
| EpilepsyNervous system disorders | 0/47 | 0/32 | 1/47 | 0/51 |
| Cholecystitis acuteHepatobiliary disorders | 0/47 | 0/32 | 0/47 | 1/51 |
| DizzinessNervous system disorders | 0/47 | 0/32 | 0/47 | 1/51 |
| Event | Placebo | 3/6 Milligrams (mg) Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 12/47 | 14/32 | 22/47 | 34/51 |
| VomitingGastrointestinal disorders | 1/47 | 7/32 | 6/47 | 24/51 |
| ConstipationGastrointestinal disorders | 5/47 | 7/32 | 14/47 | 19/51 |
| DiarrhoeaGastrointestinal disorders | 6/47 | 9/32 | 12/47 | 13/51 |
| FatigueGeneral disorders | 3/47 | 6/32 | 11/47 | 13/51 |
| Upper respiratory tract infectionInfections and infestations | 7/47 | 6/32 | 7/47 | 6/51 |
| DizzinessNervous system disorders | 3/47 | 2/32 | 3/47 | 9/51 |
| Covid-19Infections and infestations | 6/47 | 0/32 | 2/47 | 8/51 |
| Urinary tract infectionInfections and infestations | 1/47 | 3/32 | 6/47 | 4/51 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/47 | 4/32 | 1/47 | 4/51 |
All randomized participants.
| Age, Continuous(years) | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide | Total |
|---|---|---|---|---|---|
| Mean | 45.7 ± 12.5 | 48.6 ± 13.8 | 48.4 ± 10.1 | 48.3 ± 13.3 | 47.7 ± 12.3 |
| Sex: Female, Male(Participants) | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide | Total |
|---|---|---|---|---|---|
| Female | 32 | 21 | 32 | 33 | 118 |
| Male | 16 | 11 | 16 | 18 | 61 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 14 | 9 | 7 | 11 | 41 |
| Not Hispanic or Latino | 34 | 23 | 40 | 38 | 135 |
| Unknown or Not Reported | 0 | 0 | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 |
| Asian | 2 | 3 | 2 | 2 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 7 | 11 | 7 | 34 |
| White | 34 | 20 | 33 | 38 | 125 |
| More than one race | 3 | 0 | 1 | 2 | 6 |
| Unknown or Not Reported | 0 | 2 | 0 | 2 | 4 |
| Region of Enrollment(Participants) | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide | Total |
|---|---|---|---|---|---|
| United States | 48 | 32 | 48 | 51 | 179 |
| Body Weight(Kilograms (Kg)) | Placebo | 3/6 mg Mazdutide | 10 mg Mazdutide | 16 mg Mazdutide | Total |
|---|---|---|---|---|---|
| Mean | 103.1 ± 21.20 | 109.8 ± 17.71 | 108.5 ± 21.70 | 109.7 ± 20.67 | 107.6 ± 20.63 |
PDFs hosted by the registry, ClinicalTrials.gov.
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, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Nov 2023 to primary completion in Jan 2025, 14 months.
Results were first posted in Apr 2026, 1 year 2 months after primary completion.
Of 176 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's 14 months is above that.
Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Mazdutide