GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

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

A Phase 2, Parallel-Group, Double-Blind, 4-Arm Study to Investigate Weight Management With LY3305677 Compared With Placebo and in Adult Participants With Obesity or Overweight

Lead sponsor

Eli Lilly and Company

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

179

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoints

•Body Weight•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06124807

Org study ID18661

Secondary IDCWMM Master ProtocolEli Lilly and Company

Secondary IDW8M-MC-OXA1ISA Number

Timeline

Milestones

Study first posted2023-11-09actual

Study start2023-11-17actual

Primary completion2025-01-22actual

Study completion2025-07-09actual

Last update posted2026-04-21actual

Results first posted2026-04-21actual

Assets

Investigational agents

Mazdutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (30)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

MASH / liver

Safety / tolerability / PK

Weight & body composition

12 endpoints

Primary/registry result

Percent Change From Baseline in Body Weight at Week 32

Time frame:Baseline, Week 32

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change	95% CI
Placebo	-0.85	—
3/6 mg Mazdutide	-7.33	—
10 mg Mazdutide	-15.6	—
16 mg Mazdutide	-18.1	—

Primary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 32

Time frame:Baseline, Week 32

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Percent Change From Baseline in Body Weight at Week 48

Time frame:Baseline, Week 48

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change	95% CI
Placebo	-0.047	—
3/6 mg Mazdutide	-10.54	—
10 mg Mazdutide	-19.2	—
16 mg Mazdutide	-22.3	—

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, Week 32, Week 48

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kilograms (Kg)	95% CI
PlaceboWeek 32	-0.98	—
Week 48	-0.15	—
3/6 mg MazdutideWeek 32	-7.79	—
Week 48	-11.15	—
10 mg MazdutideWeek 32	-16.1	—
Week 48	-19.7	—
16 mg MazdutideWeek 32	-19.2	—
Week 48	-23.9	—

Secondary/registry result

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

Time frame:Baseline, Week 32, Week 48

threshold achievement, improvement

Posted result

Group	Value (mean), percentage of participants	95% CI
PlaceboWeek 32	23.97	—
Week 48	25.96	—
3/6 mg MazdutideWeek 32	67.64	—
Week 48	74.77	—
10 mg MazdutideWeek 32	96.10	—
Week 48	95.91	—
16 mg MazdutideWeek 32	92.23	—
Week 48	91.90	—

Secondary/registry result

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

Time frame:Baseline, Week 32, Week 48

threshold achievement, improvement

Posted result

Group	Value (mean), percentage of participants	95% CI
PlaceboWeek 32	8.73	—
Week 48	13.77	—
3/6 mg MazdutideWeek 32	45.43	—
Week 48	57.86	—
10 mg MazdutideWeek 32	85.95	—
Week 48	83.97	—
16 mg MazdutideWeek 32	77.08	—
Week 48	80.73	—

Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 32, Week 48

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram per square metre (kg/m^2)	95% CI
PlaceboWeek 32	-0.32	—
Week 48	-0.017	—
3/6 mg MazdutideWeek 32	-2.84	—
Week 48	-4.07	—
10 mg MazdutideWeek 32	-5.81	—
Week 48	-7.15	—
16 mg MazdutideWeek 32	-6.86	—
Week 48	-8.53	—

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 48

Time frame:Baseline, Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 32, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 32, Week 48

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 32, Week 48

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 32, Week 48

BMI, change

change from baseline, improvement

MASH / liver

12 endpoints

Secondary/registry result

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

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage of liver fat content	95% CI
PlaceboWeek 32	-1.62	—
Week 48	-1.35	—
3/6 mg MazdutideWeek 32	-6.15	—
Week 48	-7.81	—
10 mg MazdutideWeek 32	-7.78	—
Week 48	-8.07	—
16 mg MazdutideWeek 32	-7.91	—
Week 48	-7.74	—

Secondary/registry result

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

Time frame:Baseline, Week 32, Week 48

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change	95% CI
PlaceboWeek 32	-14.1	—
Week 48	-11.7	—
3/6 mg MazdutideWeek 32	-53.5	—
Week 48	-68.0	—
10 mg MazdutideWeek 32	-67.7	—
Week 48	-70.2	—
16 mg MazdutideWeek 32	-68.8	—
Week 48	-67.4	—

Secondary/registry result

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

Time frame:Baseline, Week 32, Week 48

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage of liver fat content	95% CI
PlaceboWeek 32	-4.3	—
Week 48	-4.6	—
3/6 mg MazdutideWeek 32	-9.3	—
Week 48	-12.4	—
10 mg MazdutideWeek 32	-13.8	—
Week 48	-13.9	—
16 mg MazdutideWeek 32	-12.8	—
Week 48	-12.6	—

Secondary/registry result

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

Time frame:Baseline, Week 32, Week 48

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change	95% CI
PlaceboWeek 32	-24.7	—
Week 48	-26.3	—
3/6 mg MazdutideWeek 32	-53.4	—
Week 48	-71.2	—
10 mg MazdutideWeek 32	-79.5	—
Week 48	-80.2	—
16 mg MazdutideWeek 32	-73.6	—
Week 48	-72.3	—

Secondary/registry result

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

Time frame:Baseline, Week 32, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), percentage of participants	95% CI
PlaceboWeek 32	24.93	—
Week 48	30.04	—
3/6 mg MazdutideWeek 32	73.97	—
Week 48	87.73	—
10 mg MazdutideWeek 32	84.93	—
Week 48	85.70	—
16 mg MazdutideWeek 32	83.40	—
Week 48	84.23	—

Secondary/registry result

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

Time frame:Baseline, Week 32, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), percentage of participants	95% CI
PlaceboWeek 32	38.57	—
Week 48	36.82	—
3/6 mg MazdutideWeek 32	71.95	—
Week 48	86.64	—
10 mg MazdutideWeek 32	99.71	—
Week 48	90.46	—
16 mg MazdutideWeek 32	92.04	—
Week 48	78.36	—

Secondary/protocol endpoint

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

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 32, Week 48

Liver fat content, change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 32, Week 48

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 32, Week 48

Liver fat content, change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 32, Week 48

MRI-PDFF ≥30% responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 32, Week 48

MRI-PDFF ≥30% responders

threshold achievement, improvement

Safety / tolerability / PK

6 endpoints

Secondary/registry result

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

Time frame:Baseline up to week 56

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	5	—
3/6 Milligrams (mg) Mazdutide	3	—
10 mg Mazdutide	10	—
16 mg Mazdutide	11	—

Secondary/registry result

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

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (ngh/mL)	95% CI
3 mg Mazdutide	93800	44800 – 199000
6 mg Mazdutide	190000	90600 – 404000
10 mg Mazdutide	340000	158000 – 758000
16 mg Mazdutide	537000	240000 – 1210000

Secondary/registry result

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

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram per milliliter (ng/mL)	95% CI
3 mg Mazdutide	694	356 – 1330
6 mg Mazdutide	1420	735 – 2880
10 mg Mazdutide	2530	1290 – 5380
16 mg Mazdutide	4020	2000 – 8020

Secondary/protocol endpoint

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

Time frame:Baseline up to week 56

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.