A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities

Lilly

Status and phase: Completed; Phase 2

Conditions: Overweight and Obesity; Obesity

Treatments: Drug: Placebo; Drug: LY3502970

Study type: Interventional

Funder types: Industry

Identifiers

NCT05051579

18210

J2A-MC-GZGI (Other Identifier)

2021-002805-88 (EudraCT Number)

Details and patient eligibility

About

The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.

Enrollment: 272 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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272 participants in 7 patient groups, including a placebo group

12 milligram (mg) LY3502970

Experimental group

Description:

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.

Treatment:

Drug: LY3502970

24 mg LY3502970

Experimental group

Description:

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.

Treatment:

Drug: LY3502970

36 mg-1 LY3502970

Experimental group

Description:

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.

Treatment:

Drug: LY3502970

36 mg-2 LY3502970

Experimental group

Description:

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.

Treatment:

Drug: LY3502970

45 mg-1 LY3502970

Experimental group

Description:

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.

Treatment:

Drug: LY3502970

45 mg-2 LY3502970

Experimental group

Description:

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.

Treatment:

Drug: LY3502970

Placebo

Placebo Comparator group

Description:

Participants received placebo administered orally once daily until 36 weeks.

Treatment:

Drug: Placebo