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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZBV | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of combined oral contraceptive (COC) ethinyl estradiol and drospirenone in the blood stream in postmenopausal female participants who are overweight or obese. The safety and tolerability of LY3437943 when administered with COC will also be evaluated. This study will last up to approximately 29 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3437943 + Combined Oral Contraceptive (COC) | Experimental | The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3437943 | Drug | Administered SC. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol | PK: AUC0-24 of Ethinyl Estradiol | Predose on Day 1 up to 144 days postdose |
| PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol | PK: Cmax of Ethinyl Estradiol | Predose on Day 1 up to 144 days postdose |
| PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol | PK: Tmax of Ethinyl Estradiol | Predose on Day 1 up to 144 days postdose |
| PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone | PK: AUC0-24 of Drospirenone | Predose on Day 1 up to 144 days postdose |
| PK: Maximum Observed Concentration (Cmax) of Drospirenone | PK: Cmax of Drospirenone | Predose on Day 1 up to 144 days postdose |
| PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone | PK: Tmax of Drospirenone | Predose on Day 1 up to 144 days postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States | ||
| ICON Early Phase Services |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C000729679 | retatrutide |
| D004997 | Ethinyl Estradiol |
| C035144 | drospirenone |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
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| Ethinyl Estradiol |
| Drug |
Administered orally |
|
| Drospirenone | Drug | Administered orally |
|
| San Antonio |
| Texas |
| 78209 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |