Retatrutide

NCT05445232 · COMPLETED

A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants

The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. This study will last up to approximately 25 weeks for each participant.

Outcomes: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam · PK: Maximum Observed Concentration (Cmax) of Midazolam · PK: AUC[0-∞] of Warfarin · PK: Cmax of Warfarin · PK: AUC[0-∞] of Caffeine · PK: Cmax of Caffeine

NCT07629401 · AVAILABLE

Pre-approval Expanded Access of Retatrutide (LY3437943)

Provide pre-approval single-patient expanded access of retatrutide (LY3437943), an investigational GLP-1/GIP/glucagon triple receptor agonist being studied for chronic weight management, for adults with severe obesity (body mass index \[BMI\] greater than or equal to \[≥\]35 kilogram per square meter \[kg/m²\] and at least two serious or life-threatening obesity-related complications who are refractory to the best approved therapy and are unable to participate in an ongoing clinical trial of retatrutide or a comparable investigational medicine.

NCT04867785 · COMPLETED

A Study of LY3437943 in Participants With Type 2 Diabetes

The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.

Outcomes: Change From Baseline in Hemoglobin A1c (HbA1c) · Change From Baseline in HbA1c · Change From Baseline in HbA1c · Percentage of Participants Reaching HbA1c <7.0% · Percentage of Participant Reaching HbA1c <7.0% · Change From Baseline in Fasting Blood Glucose (FBG) · Change From Baseline in Fasting Blood Glucose (FBG) · Change From Baseline in Body Weight · Change From Baseline in Body Weight · Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943

Results summary: {"participantFlowModule":{"preAssignmentDetails":"Four maintenance doses of LY3437943 were evaluated: 0.5 mg, 4 mg, 8 mg, and 12 mg. Dose escalation occurred in certain cohorts up to Week 12 during the 36-week treatment period. For maintenance doses equal to or greater than 4 mg, the initial dose will be 2 mg or 4 mg followed by additional escalation steps as appropriate.","groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo administered as subcutaneous (SC) injection once weekly (QW)."},{"id":"FG001","title":"1.5 Milligrams (mg) Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW."},{"id":"FG002","title":"0.5 mg LY3437943","description":"Participants received 0.5 mg LY3437943 administered as SC injection QW."},{"id":"FG003","title":"4 mg LY3437943 (2 mg)","description":"Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW."},{"id":"FG004","title":"4 mg LY3437943 (4 mg)","description":"Participants received 4 mg LY3437943 administered as SC injection QW."},{"id":"FG005","title":"8 mg LY3437943 (2 mg)","description":"Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW."},{"id":"FG006","title":"8 mg LY3437943 (4 mg)","description":"Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW."},{"id":"FG007","title":"12 mg LY3437943 (2 mg)","description":"Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"46"},{"groupId":"FG002","numSubjects":"47"},{"groupId":"FG003","numSubjects":"23"},{"groupId":"FG004","numSubjects":"24"},{"groupId":"FG005","numSubjects":"26"},{"groupId":"FG006","numSubjects":"24"},{"groupId":"FG007","numSubjects":"46"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"46"},{"groupId":"FG002","numSubjects":"47"},{"groupId":"FG003","numSubjects":"23"},{"groupId":"FG004","numSubjects":"24"},{"groupId":"FG005","numSubjects":"26"},{"groupId":"FG006","numSubjects":"24"},{"groupId":"FG007","numSubjects":"46"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"40"},{"groupId":"FG002","numSubjects":"41"},{"groupId":"FG003","numSubjects":"19"},{"groupId":"FG004","numSubjects":"21"},{"groupId":"FG005","numSubjects":"25"},{"groupId":"FG006","numSubjects":"22"},{"groupId":"FG007","numSubjects":"35"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"11"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"5"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"}]},{"type":"Inadvertent Enrollment","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"}]},{"type":"Eligibility Criteria Not Met","reasons":[{"grou

NCT06354660 · COMPLETED

Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.

Outcomes: Change from Baseline in Hemoglobin A1c (HbA1c) (%) · Percentage of Participants Who Achieve HbA1c < 7.0% · Percentage of Participants Who Achieve HbA1c ≤ 6.5% · Percentage of Participants Who Achieve HbA1c < 5.7% · Change from Baseline in Fasting Serum Glucose · Percent Change from Baseline in Body Weight · Change from Baseline in Body Weight · Percentage of Participants Who Achieve Weight Reduction of ≥ 5% · Percentage of Participants Who Achieve Weight Reduction of ≥ 10% · Percentage of Participants Who Achieve Weight Reduction of ≥ 15% · Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction · Percent Change from Baseline in Triglycerides · Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol · Change from Baseline in Systolic Blood Pressure (SBP)

NCT06039826 · COMPLETED

A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

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.

Outcomes: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Ethinyl Estradiol · PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol · PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol · PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone · PK: Maximum Observed Concentration (Cmax) of Drospirenone · PK: Time of Maximum Observed Concentration (Tmax) of Drospirenone

NCT07232719 · ACTIVE_NOT_RECRUITING

A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight

The purpose of this study is to evaluate the efficacy and safety of retatrutide compared with placebo for body weight reduction. Participation in the study will last about 65 weeks and may include about 18 visits.

Outcomes: Percent Change from Baseline in Body Weight · Change from Baseline in Systolic Blood Pressure · Change from Baseline in Waist Circumference · Percent Change from Baseline in Non-High-Density Lipoprotein (HDL) Cholesterol · Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)