Phase 2
N=179
A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
Obesity · Overweight and Obesity
Bottom Line
View on ClinicalTrials.gov: NCT06124807 ↗Enrolled (actual)
179
Serious AEs
2.8%
Results posted
Apr 2026
Primary outcome: Primary: Percent Change From Baseline in Body Weight at Week 32 — -0.85; -7.33; -15.6; -18.1 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mazdutide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Body Weight at Week 32 |
-0.85; -7.33; -15.6; -18.1 | — |
| SECONDARY Percent Change From Baseline in Body Weight at Week 48 |
-0.047; -10.54; -19.2; -22.3 | — |
| SECONDARY Change From Baseline in Body Weight |
-0.98; -7.79; -16.1; -19.2; -0.15; -11.15 | — |
| SECONDARY Mean Percentage of Participants Who Achieve ≥5% Body Weight Reduction |
23.97; 67.64; 96.10; 92.23; 25.96; 74.77 | — |
| SECONDARY Mean Percentage of Participants Who Achieve ≥10% Body Weight Reduction |
8.73; 45.43; 85.95; 77.08; 13.77; 57.86 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
-0.32; -2.84; -5.81; -6.86; -0.017; -4.07 | — |
| SECONDARY Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs) |
5; 3; 10; 11 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Curve (AUC) of Mazdutide at Steady State |
93800; 190000; 340000; 537000 | — |
| SECONDARY PK: Maximum Concentration (Cmax) of Mazdutide at Steady State |
694; 1420; 2530; 4020 | — |
| 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% |
-1.62; -6.15; -7.78; -7.91; -1.35; -7.81 | — |
| SECONDARY Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=5% |
-14.1; -53.5; -67.7; -68.8; -11.7; -68.0 | — |
| SECONDARY Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10% |
-4.3; -9.3; -13.8; -12.8; -4.6; -12.4 | — |
| SECONDARY Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10% |
-24.7; -53.4; -79.5; -73.6; -26.3; -71.2 | — |
| SECONDARY Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >= 5% Who Achieved >30% Relative Reduction in LFC |
24.93; 73.97; 84.93; 83.40; 30.04; 87.73 | — |
| SECONDARY Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >=10% Who Achieved >30% Relative Reduction in LFC |
38.57; 71.95; 99.71; 92.04; 36.82; 86.64 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06124807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.