A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)

Lilly

Status and phase: Completed; Phase 3

Conditions: Overweight; Metabolism and Nutrition Disorder; Obesity

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05024032

17507

I8F-MC-GPIA (Other Identifier)

Details and patient eligibility

About

This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight.

The main purpose is to learn more about how tirzepatide affects body weight.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
• Have a history of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion criteria

• Have Diabetes Mellitus
• Have a self-reported change in body weight >5 kg within 3 months prior to screening
• Have obesity induced by other endocrinological disorders
• Have had a history of chronic or acute pancreatitis
• Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years
• Have any lifetime history of a suicide attempt
• Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 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 SC QW.

Treatment:

Drug: Placebo