Obesity, Overweight and Obesity
Conditions
Brief summary
The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.
Interventions
DRUGLY3502970
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
* Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²) * Have a BMI ≥27 kg/m² and \<30 kg/m² with at least 1 of the following weight-related comorbidities eg; \[Have hypertension, or dyslipidemia, cardiovascular disease\] * Have had a stable body weight for the 3 months prior to randomization (not more than 5% body weight gain and/or loss)
Exclusion criteria
* Have any prior diagnosis of diabetes * Have a prior or planned surgical treatment for obesity * Have obesity induced by other endocrinological disorders or diagnosed monogenetic or syndromic forms of obesity * Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 milliliter (mL)/minute (min)/1.73 m² * Have a history of acute chronic pancreatitis * Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, may be considered for inclusion if they are not on excluded medications. Within 3 months prior to screening: * Have poorly controlled hypertension * Have history of acute myocardial infarction * Have history of cerebrovascular accident (stroke) * Had hospitalization due to congestive heart failure (CHF) * Have cancer * Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening * Have hepatitis B and/or positive hepatitis B surface antigen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Body Weight in LY3502970 and Placebo | Baseline, Week 26 | Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight in LY3502970 and Placebo | Baseline, Week 26 | LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. |
| Change From Baseline in Waist Circumference in LY3502970 and Placebo | Baseline, Week 26 | LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. |
| Percent Change From Baseline in Body Weight in LY3502970 and Placebo | Baseline, Week 36 | LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. |
| Percentage of Participants With >=5% Body Weight Loss | Week 26 | Percentage of participants with \>=5% body weight loss was reported. |
| Percentage of Participants With >=10% Body Weight Loss | Week 26 | Percentage of participants with \>=10% body weight loss was reported. |
| Change From Baseline in BMI in LY3502970 and Placebo | Baseline, Week 26 | LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. |
Countries
Canada, Hungary, Puerto Rico, United States
Participant flow
Pre-assignment details
For maintenance doses of LY3502970: 12, 24, 36, and 45 milligram (mg), the initial dose will be 2 or 3 mg followed by additional escalation steps as appropriate. The dose-escalation varied by dose group where the target maintenance dose was achieved between Weeks 5 and 16.
Participants by arm
| Arm | Count |
|---|---|
| 12 mg LY3502970 Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks. | 50 |
| 24 mg LY3502970 Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks. | 53 |
| 36 mg -1 LY3502970 Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks. | 29 |
| 36 mg -2 LY3502970 Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks. | 29 |
| 45 mg -1 LY3502970 Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks. | 31 |
| 45 mg -2 LY3502970 Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks. | 30 |
| Placebo Participants received placebo administered orally once daily until 36 weeks. | 50 |
| Total | 272 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 | 4 | 1 | 2 | 0 |
| Overall Study | Inadvertent Enrollment | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Patient was Initially Long Term Follow-up But Contacted and came to Site After Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Sponsor Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Subject Could not Tolerate Investigational Product (IP) and was Taken Off | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Subject Unable to Visit Due to Working Out of Town | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 5 | 2 | 1 | 4 | 0 | 4 |
Baseline characteristics
| Characteristic | 24 mg LY3502970 | 36 mg -1 LY3502970 | 36 mg -2 LY3502970 | 45 mg -1 LY3502970 | 12 mg LY3502970 | 45 mg -2 LY3502970 | Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 57.00 years STANDARD_DEVIATION 9.09 | 56.30 years STANDARD_DEVIATION 11.83 | 55.40 years STANDARD_DEVIATION 10.93 | 56.50 years STANDARD_DEVIATION 10.74 | 49.80 years STANDARD_DEVIATION 10.51 | 50.90 years STANDARD_DEVIATION 12.58 | 54.00 years STANDARD_DEVIATION 8.82 | 54.20 years STANDARD_DEVIATION 10.67 |
| Baseline Body Weight | 112.05 Kilograms (kg) STANDARD_DEVIATION 30.18 | 107.78 Kilograms (kg) STANDARD_DEVIATION 22.45 | 108.84 Kilograms (kg) STANDARD_DEVIATION 28.52 | 105.23 Kilograms (kg) STANDARD_DEVIATION 20.4 | 107.49 Kilograms (kg) STANDARD_DEVIATION 25.34 | 110.85 Kilograms (kg) STANDARD_DEVIATION 28.11 | 107.57 Kilograms (kg) STANDARD_DEVIATION 25.24 | 108.68 Kilograms (kg) STANDARD_DEVIATION 26.03 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 2 Participants | 4 Participants | 11 Participants | 7 Participants | 5 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 23 Participants | 26 Participants | 25 Participants | 38 Participants | 22 Participants | 43 Participants | 223 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 4 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 46 Participants | 25 Participants | 25 Participants | 29 Participants | 47 Participants | 30 Participants | 45 Participants | 247 Participants |
| Region of Enrollment Canada | 11 Participants | 5 Participants | 3 Participants | 9 Participants | 9 Participants | 5 Participants | 6 Participants | 48 Participants |
| Region of Enrollment Hungary | 5 Participants | 3 Participants | 6 Participants | 3 Participants | 6 Participants | 3 Participants | 5 Participants | 31 Participants |
| Region of Enrollment United States | 37 Participants | 21 Participants | 20 Participants | 19 Participants | 35 Participants | 22 Participants | 39 Participants | 193 Participants |
| Sex: Female, Male Female | 30 Participants | 18 Participants | 18 Participants | 19 Participants | 31 Participants | 16 Participants | 29 Participants | 161 Participants |
| Sex: Female, Male Male | 23 Participants | 11 Participants | 11 Participants | 12 Participants | 19 Participants | 14 Participants | 21 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 53 | 0 / 29 | 0 / 29 | 0 / 31 | 0 / 30 | 0 / 50 |
| other Total, other adverse events | 35 / 50 | 46 / 53 | 23 / 29 | 25 / 29 | 26 / 31 | 24 / 30 | 27 / 50 |
| serious Total, serious adverse events | 0 / 50 | 2 / 53 | 0 / 29 | 3 / 29 | 2 / 31 | 0 / 30 | 0 / 50 |
Outcome results
Primary
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time frame: Baseline, Week 26
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3502970 | Percent Change From Baseline in Body Weight in LY3502970 and Placebo | -8.6 Percent change | Standard Error 0.85 |
| 24 mg LY3502970 | Percent Change From Baseline in Body Weight in LY3502970 and Placebo | -11.2 Percent change | Standard Error 0.82 |
| 36 mg LY3502970 | Percent Change From Baseline in Body Weight in LY3502970 and Placebo | -12.3 Percent change | Standard Error 0.77 |
| 45 mg LY3502970 | Percent Change From Baseline in Body Weight in LY3502970 and Placebo | -12.6 Percent change | Standard Error 0.75 |
| Placebo | Percent Change From Baseline in Body Weight in LY3502970 and Placebo | -2.0 Percent change | Standard Error 0.81 |
p-value: <0.00195% CI: [-8.9, -4.2]Mixed Models Analysis
p-value: <0.00195% CI: [-11.5, -6.9]Mixed Models Analysis
p-value: <0.00195% CI: [-12.4, -8]Mixed Models Analysis
p-value: <0.00195% CI: [-12.7, -8.4]Mixed Models Analysis
Secondary
Change From Baseline in BMI in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time frame: Baseline, Week 36
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3502970 | Change From Baseline in BMI in LY3502970 and Placebo | -3.4 kg/m^2 | Standard Error 0.38 |
| 24 mg LY3502970 | Change From Baseline in BMI in LY3502970 and Placebo | -4.7 kg/m^2 | Standard Error 0.36 |
| 36 mg LY3502970 | Change From Baseline in BMI in LY3502970 and Placebo | -5.0 kg/m^2 | Standard Error 0.34 |
| 45 mg LY3502970 | Change From Baseline in BMI in LY3502970 and Placebo | -5.5 kg/m^2 | Standard Error 0.34 |
| Placebo | Change From Baseline in BMI in LY3502970 and Placebo | -0.9 kg/m^2 | Standard Error 0.36 |
p-value: <0.00195% CI: [-3.6, -1.5]Mixed Models Analysis
p-value: <0.00195% CI: [-4.8, -2.8]Mixed Models Analysis
p-value: <0.00195% CI: [-5.2, -3.2]Mixed Models Analysis
p-value: <0.00195% CI: [-5.6, -3.6]Mixed Models Analysis
Secondary
Change From Baseline in BMI in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time frame: Baseline, Week 26
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3502970 | Change From Baseline in BMI in LY3502970 and Placebo | -3.2 kilograms per meter square (kg/m^2) | Standard Error 0.31 |
| 24 mg LY3502970 | Change From Baseline in BMI in LY3502970 and Placebo | -4.2 kilograms per meter square (kg/m^2) | Standard Error 0.3 |
| 36 mg LY3502970 | Change From Baseline in BMI in LY3502970 and Placebo | -4.6 kilograms per meter square (kg/m^2) | Standard Error 0.28 |
| 45 mg LY3502970 | Change From Baseline in BMI in LY3502970 and Placebo | -4.7 kilograms per meter square (kg/m^2) | Standard Error 0.27 |
| Placebo | Change From Baseline in BMI in LY3502970 and Placebo | -0.8 kilograms per meter square (kg/m^2) | Standard Error 0.29 |
p-value: <0.00195% CI: [-3.2, -1.6]Mixed Models Analysis
p-value: <0.00195% CI: [-4.3, -2.6]Mixed Models Analysis
p-value: <0.00195% CI: [-4.6, 3]Mixed Models Analysis
p-value: <0.00195% CI: [-4.7, -3.1]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time frame: Baseline, Week 26
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3502970 | Change From Baseline in Body Weight in LY3502970 and Placebo | -9.0 kg | Standard Error 0.9 |
| 24 mg LY3502970 | Change From Baseline in Body Weight in LY3502970 and Placebo | -12.3 kg | Standard Error 0.86 |
| 36 mg LY3502970 | Change From Baseline in Body Weight in LY3502970 and Placebo | -12.9 kg | Standard Error 0.82 |
| 45 mg LY3502970 | Change From Baseline in Body Weight in LY3502970 and Placebo | -13.3 kg | Standard Error 0.79 |
| Placebo | Change From Baseline in Body Weight in LY3502970 and Placebo | -2.1 kg | Standard Error 0.86 |
p-value: <0.00195% CI: [-9.3, -4.4]Mixed Models Analysis
p-value: <0.00195% CI: [-12.5, -7.8]Mixed Models Analysis
p-value: <0.00195% CI: [-13.1, -8.5]Mixed Models Analysis
p-value: <0.00195% CI: [-13.5, -8.9]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time frame: Baseline, Week 36
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3502970 | Change From Baseline in Body Weight in LY3502970 and Placebo | -9.8 kg | Standard Error 1.1 |
| 24 mg LY3502970 | Change From Baseline in Body Weight in LY3502970 and Placebo | -13.6 kg | Standard Error 1.06 |
| 36 mg LY3502970 | Change From Baseline in Body Weight in LY3502970 and Placebo | -14.2 kg | Standard Error 1 |
| 45 mg LY3502970 | Change From Baseline in Body Weight in LY3502970 and Placebo | -15.4 kg | Standard Error 0.98 |
| Placebo | Change From Baseline in Body Weight in LY3502970 and Placebo | -2.4 kg | Standard Error 1.05 |
p-value: <0.00195% CI: [-14.7, -9]Mixed Models Analysis
p-value: <0.00195% CI: [-10.4, -4.3]Mixed Models Analysis
p-value: <0.00195% CI: [-14.2, -8.3]Mixed Models Analysis
p-value: <0.00195% CI: [-15.8, -10.2]Mixed Models Analysis
Secondary
Change From Baseline in Waist Circumference in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time frame: Baseline, Week 36
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body waist circumference value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3502970 | Change From Baseline in Waist Circumference in LY3502970 and Placebo | -9.6 cm | Standard Error 1.18 |
| 24 mg LY3502970 | Change From Baseline in Waist Circumference in LY3502970 and Placebo | -11.2 cm | Standard Error 1.15 |
| 36 mg LY3502970 | Change From Baseline in Waist Circumference in LY3502970 and Placebo | -10.6 cm | Standard Error 1.06 |
| 45 mg LY3502970 | Change From Baseline in Waist Circumference in LY3502970 and Placebo | -13.6 cm | Standard Error 1.07 |
| Placebo | Change From Baseline in Waist Circumference in LY3502970 and Placebo | -4.0 cm | Standard Error 1.12 |
p-value: <0.00195% CI: [-8.8, -2.4]Mixed Models Analysis
p-value: <0.00195% CI: [-10.3, -4]Mixed Models Analysis
p-value: <0.00195% CI: [-9.7, -3.6]Mixed Models Analysis
p-value: <0.00195% CI: [-12.7, -6.6]Mixed Models Analysis
Secondary
Change From Baseline in Waist Circumference in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time frame: Baseline, Week 26
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body waist circumference value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3502970 | Change From Baseline in Waist Circumference in LY3502970 and Placebo | -8.0 centimeter (cm) | Standard Error 1.03 |
| 24 mg LY3502970 | Change From Baseline in Waist Circumference in LY3502970 and Placebo | -8.8 centimeter (cm) | Standard Error 1 |
| 36 mg LY3502970 | Change From Baseline in Waist Circumference in LY3502970 and Placebo | -10.1 centimeter (cm) | Standard Error 0.94 |
| 45 mg LY3502970 | Change From Baseline in Waist Circumference in LY3502970 and Placebo | -12.2 centimeter (cm) | Standard Error 0.93 |
| Placebo | Change From Baseline in Waist Circumference in LY3502970 and Placebo | -3.6 centimeter (cm) | Standard Error 0.99 |
p-value: 0.00295% CI: [-7.2, -1.6]Mixed Models Analysis
p-value: <0.00195% CI: [-8, -2.4]Mixed Models Analysis
p-value: <0.00195% CI: [-9.2, -3.8]Mixed Models Analysis
p-value: <0.00195% CI: [-11.3, -6]Mixed Models Analysis
Secondary
Percentage of Participants With >=10% Body Weight Loss
Percentage of participants with \>=10% body weight loss was reported.
Time frame: Week 36
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% body weight reduction.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 12 mg LY3502970 | Percentage of Participants With >=10% Body Weight Loss | 46.50 percentage of participants |
| 24 mg LY3502970 | Percentage of Participants With >=10% Body Weight Loss | 61.88 percentage of participants |
| 36 mg LY3502970 | Percentage of Participants With >=10% Body Weight Loss | 74.75 percentage of participants |
| 45 mg LY3502970 | Percentage of Participants With >=10% Body Weight Loss | 69.07 percentage of participants |
| Placebo | Percentage of Participants With >=10% Body Weight Loss | 8.85 percentage of participants |
p-value: <0.00195% CI: [2.59, 26.45]Regression, Logistic
p-value: <0.00195% CI: [4.83, 50.68]Regression, Logistic
p-value: <0.00195% CI: [8.39, 88.38]Regression, Logistic
p-value: <0.00195% CI: [6.59, 66.17]Regression, Logistic
Secondary
Percentage of Participants With >=10% Body Weight Loss
Percentage of participants with \>=10% body weight loss was reported.
Time frame: Week 26
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% body weight reduction.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 12 mg LY3502970 | Percentage of Participants With >=10% Body Weight Loss | 39.39 percentage of participants |
| 24 mg LY3502970 | Percentage of Participants With >=10% Body Weight Loss | 56.61 percentage of participants |
| 36 mg LY3502970 | Percentage of Participants With >=10% Body Weight Loss | 71.30 percentage of participants |
| 45 mg LY3502970 | Percentage of Participants With >=10% Body Weight Loss | 69.86 percentage of participants |
| Placebo | Percentage of Participants With >=10% Body Weight Loss | 2.25 percentage of participants |
p-value: <0.00195% CI: [3.47, 114.4]Regression, Logistic
p-value: <0.00195% CI: [6.95, 224.83]Regression, Logistic
p-value: <0.00195% CI: [13.16, 427.18]Regression, Logistic
p-value: <0.00195% CI: [12.62, 413.21]Regression, Logistic
Secondary
Percentage of Participants With >=5% Body Weight Loss
Percentage of participants with \>=5% body weight loss was reported.
Time frame: Week 36
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% body weight reduction.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 12 mg LY3502970 | Percentage of Participants With >=5% Body Weight Loss | 72.00 percentage of participants |
| 24 mg LY3502970 | Percentage of Participants With >=5% Body Weight Loss | 89.47 percentage of participants |
| 36 mg LY3502970 | Percentage of Participants With >=5% Body Weight Loss | 92.05 percentage of participants |
| 45 mg LY3502970 | Percentage of Participants With >=5% Body Weight Loss | 90.44 percentage of participants |
| Placebo | Percentage of Participants With >=5% Body Weight Loss | 24.02 percentage of participants |
p-value: <0.00195% CI: [2.9, 20.92]Regression, Logistic
p-value: <0.00195% CI: [7.49, 83.91]Regression, Logistic
p-value: <0.00195% CI: [8.17, 147.86]Regression, Logistic
p-value: <0.00195% CI: [8.15, 96.29]Regression, Logistic
Secondary
Percentage of Participants With >=5% Body Weight Loss
Percentage of participants with \>=5% body weight loss was reported.
Time frame: Week 26
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% body weight reduction.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 12 mg LY3502970 | Percentage of Participants With >=5% Body Weight Loss | 74.39 percentage of participants |
| 24 mg LY3502970 | Percentage of Participants With >=5% Body Weight Loss | 88.84 percentage of participants |
| 36 mg LY3502970 | Percentage of Participants With >=5% Body Weight Loss | 89.46 percentage of participants |
| 45 mg LY3502970 | Percentage of Participants With >=5% Body Weight Loss | 87.26 percentage of participants |
| Placebo | Percentage of Participants With >=5% Body Weight Loss | 22.88 percentage of participants |
p-value: <0.00195% CI: [3.61, 27.44]Regression, Logistic
p-value: <0.00195% CI: [8.15, 96.01]Regression, Logistic
p-value: <0.00195% CI: [8.71, 85.91]Regression, Logistic
p-value: <0.00195% CI: [7.65, 72.77]Regression, Logistic
Secondary
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time frame: Baseline, Week 36
Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3502970 | Percent Change From Baseline in Body Weight in LY3502970 and Placebo | -9.4 Percent change | Standard Error 1.05 |
| 24 mg LY3502970 | Percent Change From Baseline in Body Weight in LY3502970 and Placebo | -12.5 Percent change | Standard Error 1.01 |
| 36 mg LY3502970 | Percent Change From Baseline in Body Weight in LY3502970 and Placebo | -13.5 Percent change | Standard Error 0.95 |
| 45 mg LY3502970 | Percent Change From Baseline in Body Weight in LY3502970 and Placebo | -14.7 Percent change | Standard Error 0.94 |
| Placebo | Percent Change From Baseline in Body Weight in LY3502970 and Placebo | -2.3 Percent change | Standard Error 1 |
p-value: <0.00195% CI: [-9.9, -4.2]Mixed Models Analysis
p-value: <0.00195% CI: [-12.9, -7.3]Mixed Models Analysis
p-value: <0.00195% CI: [-13.8, -8.4]Mixed Models Analysis
p-value: <0.00195% CI: [-15, -9.6]Mixed Models Analysis