ObesityPhase 2NCT06124807
A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
A Phase 2 study testing Mazdutide in people with Obesity and Overweight and Obesity, run by Eli Lilly and Company at 29 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Overweight and Obesity
- What is being tested?
- Mazdutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 29 sitesUnited States
- Study dates
- 17 Nov 2023to 9 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Dent Neurologic Institute
Amherst, New York, 14226
IMA Clinical Research Austin
Austin, Texas, 78745
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, 85225
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
CTI Clinical Research Center
Cincinnati, Ohio, 45212
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Spectrum Medical, Inc.
Danville, Virginia, 24541
Northeast Research Institute (NERI)
Fleming Island, Florida, 32003
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817
PlanIt Research, PLLC
Houston, Texas, 77079
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
Las Vegas Medical Research
Las Vegas, Nevada, 89128
L-MARC Research Center
Louisville, Kentucky, 40213
Quality Medical Research
Nashville, Tennessee, 37211
Knownwell
Needham, Massachusetts, 02492
Lucas Research, Inc.
New Bern, North Carolina, 28562
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Charter Research - Winter Park
Orlando, Florida, 32803
North Suffolk Neurology
Port Jefferson Station, New York, 11776
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Tekton Research - Fredericksburg Road
San Antonio, Texas, 78229
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
Charter Research - Lady Lake
The Villages, Florida, 32162
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, 85712
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801
About this study
Official title: 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
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.
- Conditions
- Obesity, Overweight and Obesity
- Being tested
- Mazdutide, Placebo
- Keywords
- Incretins, Weight Loss, Overnutrition
- Medical subject headings
- Obesity, Overweight, Weight Loss, Overnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MazdutideDrug
Also called LY3305677
Administered subcutaneous (SC)
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 3/6 Milligrams (mg) Mazdutide | Experimental | 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. Receives: Drug: Mazdutide |
| 10 mg Mazdutide | Experimental | 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. Receives: Drug: Mazdutide |
| 16 mg Mazdutide | Experimental | 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. Receives: Drug: Mazdutide |
| Placebo | Placebo comparator | Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Week 32
Secondary outcomes (14)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, Week 32, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start17 Nov 2023
- Primary completion22 Jan 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124807
- Sponsor's protocol ID
- 18661
- Other IDs
- W8M-MC-OXA1, CWMM Master Protocol
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2023
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Hsia SH, Bays HE, Billings LK, Weideman AMK, Mather KJ, Coskun T, Haupt A, Thomas MK, Tham LS, Calderon B, Ni W, De Araujo OFG. Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial. Lancet Diabetes Endocrinol. 2026 Aug 21:S2213-8587(26)00160-9. doi: 10.1016/S2213-8587(26)00160-9. Online ahead of print.
PubMed 42628555
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06124807
- Acronym / sponsor ID
- 18661
- Conditions
- Obesity, Overweight and Obesity
- Keywords
- Incretins, Weight Loss, Overnutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Posted 21 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3/6 Milligrams (mg) Mazdutide | Experimental | Drug: MazdutideParticipants 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. |
| 10 mg Mazdutide | Experimental | Drug: MazdutideParticipants 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. |
| 16 mg Mazdutide | Experimental | Drug: MazdutideParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are males and females who agree to abide by the reproductive and contraceptive requirements
- Have a BMI ≥27 kilograms per square meter (kg/m²)
Key exclusion criteria (18 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MazdutideAlso: LY3305677Administered subcutaneous (SC) | Drug | 10 mg Mazdutide, 16 mg Mazdutide, 3/6 Milligrams (mg) Mazdutide |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
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).
14 secondary outcomes
Percent Change From Baseline in Body Weight at Week 48
Time frame: Baseline, Week 48
Change From Baseline in Body Weight
Time frame: Baseline, Week 32, Week 48
Mean Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Time frame: Baseline, Week 32, Week 48
Mean Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time frame: Baseline, Week 32, Week 48
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 32, Week 48
Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs)
Time frame: Baseline up to week 56
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: 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
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
Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=5%
Time frame: Baseline, Week 32, Week 48
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 in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%
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
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
Time frame: Baseline, Week 32, Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42628555Hsia SH, Bays HE, Billings LK, Weideman AMK, Mather KJ, Coskun T, Haupt A, Thomas MK, Tham LS, Calderon B, Ni W, De Araujo OFG. Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial. Lancet Diabetes Endocrinol. 2026 Aug 21:S2213-8587(26)00160-9. doi: 10.1016/S2213-8587(26)00160-9. Online ahead of print.
- A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or OverweightLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mazdutide in people with Obesity and Overweight and Obesity, run by Eli Lilly and Company at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Body Weight at Week 32 (time frame: Baseline, Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06124807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.