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

NCT04844918 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 17506I8F-JE-GPHZ
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Obesity

Keywords

Metabolism and Nutrition Disorder; Obesity Related Health Problems; Obesity Disease

Outcome Measures

Primary Outcomes (2)

• Mean Percent Change in Body Weight

  Mean percent change in body weight was measured. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + impaired glucose tolerance (IGT) at Screening + Hyperlipidemia at Screening + non-alcoholic fatty liver disease (NAFLD) at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  Baseline, 72 Weeks

• Percentage of Participants Who Achieve ≥5% Body Weight Reduction

  Percentage of Participants Who Achieve ≥5% Body Weight Reduction

  Week 72

Secondary Outcomes (24)

• Percentage of Participants Who Had Improvement in Obesity-related Health Problems

  Week 72

• Change From Baseline in Fasting Glucose for Participants With IGT at Baseline

  Baseline, Week 72

• Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline

  Baseline, Week 72

• Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline

  Baseline, Week 72

• Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]

  Baseline, Week 72

Study Arms (3)

10 Milligrams (mg) Tirzepatide

EXPERIMENTAL

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).

Drug: Tirzepatide

15 mg Tirzepatide

EXPERIMENTAL

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.

Drug: Tirzepatide

Placebo

PLACEBO COMPARATOR

Participants received matching placebo administered SC QW.

Other: Placebo

Interventions

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

10 Milligrams (mg) Tirzepatide; 15 mg Tirzepatide

Placebo OTHER

Administered SC

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (18)

Kohnodai Hospital, National Center for Global Health and Medicine

Ichikawa, Chiba, 272-8516, Japan

Location

Saiseikai Matsuyama Hospital

Matsuyama, Ehime, 791-8026, Japan

Location

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, 247-0056, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, 2308765, Japan

Location

Motomachi Takatsuka Naika Clinic

Yokohama, Kanagawa, 231-0023, Japan

Location

Osaka Saiseikai Suita hospital

Suita, Osaka, 564-0013, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, 565-0853, Japan

Location

Takatsuki Red Cross Hospital

Takatsuki, Osaka, 569-1045, Japan

Location

The Institute for Adult Disease, Asahi Life Foundation

Chuo-ku, Tokyo, 103-0002, Japan

Location

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, 103-0027, Japan

Location

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, 103-0028, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Saiseikai Central Hospital

Minato-Ku, Tokyo, 108-0073, Japan

Location

Shimokitazawa Tomo Clinic

Setagaya-ku, Tokyo, 155-0031, Japan

Location

Miho Clinic

Shinagawa-ku, Tokyo, 141 0032, Japan

Location

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, 160 0008, Japan

Location

Yamagata Tokushukai Hospital

Yamagata, Yamagata, 990-0834, Japan

Location

AMC Nishiumeda Clinic

Osaka, 530-0001, Japan

Location

Related Publications (2)

• Yokote K, Fukushima Y, Shingaki T, Oura T, Ogawa W. Association of baseline characteristics with clinical outcomes of tirzepatide treatment in Japanese patients with obesity disease: A subgroup analysis of the SURMOUNT-J trial. Diabetes Obes Metab. 2026 Feb;28(2):1278-1287. doi: 10.1111/dom.70315. Epub 2025 Nov 25.

  PMID: 41290555 DERIVED

• Kadowaki T, Kiyosue A, Shingaki T, Oura T, Yokote K. Efficacy and safety of once-weekly tirzepatide in Japanese patients with obesity disease (SURMOUNT-J): a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Lancet Diabetes Endocrinol. 2025 May;13(5):384-396. doi: 10.1016/S2213-8587(24)00377-2. Epub 2025 Feb 28.

  PMID: 40031941 DERIVED

MeSH Terms

Conditions

Obesity; Nutrition Disorders

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 14, 2021
• Study Start: May 10, 2021
• Primary Completion: June 24, 2023
• Study Completion: June 24, 2023
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

JP (18)