A Study of LY3549492 in Adults With Obesity or Overweight... | NCT07030868

ID	Type	Description	Link
W8M-MC-GN02	Other Identifier	Eli Lilly and Company
W8M-MC-CWMM	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated for strategic business reasons

Expanded Access Info

Start Date

Jun 19, 2025Actual

Primary Completion Date

Jul 29, 2025Actual

Completion Date

Jul 29, 2025Actual

First Submitted Date

Jun 13, 2025

First Submission Date that Met QC Criteria

Jun 13, 2025

First Posted Date

Jun 22, 2025Actual

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

Aug 25, 2025

Last Update Posted Date

Aug 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of treatment with LY3549492 compared to placebo in adult participants with obesity or who are overweight with type 2 diabetes.

Participation in the study will last about 11 months.

Detailed Description

Not provided

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

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY3549492 Dose 1	Experimental	Participants will receive LY3549492 orally	Drug: LY6249492
LY3549492 Dose 2 Fast Titration	Experimental	Participants will receive LY3549492 orally	Drug: LY6249492
LY3549492 Dose 2 Slow Titration	Experimental	Participants will receive LY3549492 orally	Drug: LY6249492
Placebo	Placebo Comparator	Participants will receive placebo orally	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY6249492	Drug	Administered orally	LY3549492 Dose 1 LY3549492 Dose 2 Fast Titration LY3549492 Dose 2 Slow Titration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change from Baseline in Body Weight		Baseline, Week 32

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Body Weight		Baseline, Week 32
Percentage of Participants Who Achieve ≥5% Body Weight Reduction		Baseline, Week 32
Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

W8M-MC-GN02:

Assigned male at birth
Assigned female at birth, who are of non-childbearing potential
Have type 2 diabetes

W8M-MC-CWMM:

Have a BMI ≥27 kilograms per square meter (kg/m²)
Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss

Exclusion Criteria:

W8M-MC-GN02:

Individuals who are of childbearing potential
Have a history of acute or chronic pancreatitis
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.

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 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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HOPE Research Institute		Phoenix	Arizona	85032	United States
Headlands Research - Scottsdale

Label	URL
A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes	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 or 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
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D009765	Obesity
D050177	Overweight
D003924	Diabetes Mellitus, Type 2