Obesity, Overweight, Type 2 Diabetes
Conditions
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.
Interventions
DRUGLY3549492
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Body Weight | Baseline, Week 32 | Percent change from baseline in body weight at Week 32. Body weight was intended to be measured in kilograms, and percent change was to be calculated relative to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight | Baseline, Week 32 | Change from baseline in body weight at Week 32. Body weight was intended to be measured in kilograms, and absolute change from baseline was to be calculated. |
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Baseline, Week 32 | Percentage of participants who achieved at least 5% reduction in body weight from baseline to Week 32. |
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Baseline, Week 32 | Percentage of participants who achieved at least 10% reduction in body weight from baseline to Week 32. |
| Change From Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 32 | Change from baseline in hemoglobin A1c (HbA1c) at Week 32. HbA1c was intended to be measured as a percentage and reflects average blood glucose levels over approximately 3 months. |
| Pharmacokinetics (PK): Average Concentration of LY3549492 | Week 0 and Week 24 (6-18 hours post-dose); Weeks 3, 9, 15, and 18 (1-3 hours post-dose); Weeks 6 and 21 (3-6 hours post-dose); Week 12 (1-6 hours post-dose); and Weeks 30 and 32 (pre-dose). | Average plasma concentration of LY3549492. Pharmacokinetic samples were intended to be collected at multiple timepoints, including pre-dose and post-dose intervals, to evaluate the pharmacokinetic profile of LY3549492 over time. |
Countries
Argentina, United States
Contacts
STUDY_DIRECTORCall 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
Participant flow
Recruitment details
The study was terminated for strategic business reasons after the enrollment of 1 participant. The enrolled participant did not receive any study intervention and did not undergo any post-baseline assessments prior to study termination. Therefore, no outcome measures or safety data were collected, and no analyses could be performed.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed