A Study to Investigate Weight Management With LY3549492 C... | NCT06683508

ID	Type	Description	Link
W8M-MC-GN01	Other Identifier	Eli Lilly and Company
W8M-MC-CWMM	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 13, 2024Actual

Primary Completion Date

Jan 7, 2026Actual

Completion Date

May 4, 2026Actual

First Submitted Date

Nov 8, 2024

First Submission Date that Met QC Criteria

Nov 8, 2024

First Posted Date

Nov 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2026

Last Update Posted Date

May 13, 2026Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

288Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY3549492 Dose 1	Experimental	Participants will receive LY3549492 orally	Drug: LY3549492
LY3549492 Dose 2	Experimental	Participants will receive LY3549492 orally	Drug: LY3549492
LY3549492 Dose 3	Experimental	Participants will receive LY3549492 orally	Drug: LY3549492
LY3549492 Dose 4	Experimental	Participants will receive LY3549492 orally	Drug: LY3549492
LY3549492 Dose 5	Experimental	Participants will receive LY3549492 orally	Drug: LY3549492
Placebo	Placebo Comparator	Participants will receive Placebo orally	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY3549492	Drug	Administered orally	LY3549492 Dose 1 LY3549492 Dose 2 LY3549492 Dose 3 LY3549492 Dose 4 LY3549492 Dose 5

Measure	Description	Time Frame
Percent Change from Baseline in Body Weight		Baseline, Week 36

Measure	Description	Time Frame
Change from Baseline in Body Weight (kilograms)		Baseline, Week 36
Percentage of Participants who Achieve ≥5% Body Weight Reduction		Baseline, Week 36
Percentage of Participants who Achieve ≥10% Body Weight Reduction

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

W8M-MC-GN01:

Assigned male at birth
Assigned female at birth, who are of non-childbearing potential

W8M-MC-CWMM:

Have a BMI of
- ≥ 30 kilograms per square meter (kg/m²) or
- ≥ 27 kg/m² and < 30 kg/m² with at least one weight-related comorbidity
Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)

Exclusion Criteria:

W8M-MC-GN01:

Have Type 2 Diabetes Mellitus or Type 1 Diabetes Mellitus
Have a history of acute or chronic pancreatitis
Have renal impairment
Individuals who are of childbearing potential

W8M-MC-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 any of the following cardiovascular conditions within 3 months prior to screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- unstable angina, or
- hospitalization due to congestive heart failure.
Have a history of symptomatic gallbladder disease within the past 2 years
Have a lifetime history of suicide attempts.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
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)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa		Chandler	Arizona	85225	United States

Label	URL
A Study to Investigate Weight Management with LY3549492 Compared with Placebo in Adult Participants With Obesity or Overweight	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and 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.

URL

https://vivli.org/

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms