A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease (SURMOUNT-J)

Lilly

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Other: Placebo; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04844918

I8F-JE-GPHZ (Other Identifier)

17506

Details and patient eligibility

About

The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.

Enrollment: 267 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a BMI of greater than or equal to ≥27 kg/m² and <less than 35 kg/m² with at least 2 obesity-related health problems or ≥35 kg/m² with at least 1 obesity-related health problems. Health problems are IGT, hyperlipidemia, or NAFLD.
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

• Have diabetes.
• Acute or chronic liver disease other than NAFLD.
• Have a self-reported change in body weight >5 kg within 3 months prior to screening.
• Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months.
• Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, calculated by Japanese Society of Nephrology coefficient-modified Chronic Kidney Disease-Epidemiology equation during screening.
• Have a known clinically significant gastric emptying abnormality.
• Have had a history of chronic or acute pancreatitis.
• Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (μIU/mL) at screening.
• Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
• Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.
• Have a cardiovascular condition within 3 months prior to randomization
• Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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267 participants in 3 patient groups, including a placebo group

10 Milligrams (mg) Tirzepatide

Experimental group

Description:

Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).

Treatment:

Drug: Tirzepatide

15 mg Tirzepatide

Experimental group

Description:

Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants received matching placebo administered SC QW.

Treatment:

Other: Placebo