A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide

NCT04081337 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17092I8F-MC-GPGU
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study lasted for 28 weeks and will include about 21 visits to the study center.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR)

  SMR was measured using whole-room indirect calorimetry (respiratory chamber). Change from Baseline to Week 18 in SMR was evaluated. Least square (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables.

  Baseline, Week 18

Secondary Outcomes (15)

• Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal

  Baseline, Week 18

• Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE)

  Baseline, Week 18

• Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ)

  Baseline, Week 18

• Change From Baseline to Week 18 in Sleep RQ

  Baseline, Week 18

• Change From Baseline to Week 18 in Duration of Periods With RQ<0.80

  Baseline, Week 18

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received placebo once weekly (QW) by Subcutaneous (SC) injection.

Drug: Placebo

15 Milligram (mg) Tirzepatide

EXPERIMENTAL

Participants received 15 mg of tirzepatide QW by SC injection.

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

15 Milligram (mg) Tirzepatide

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive
• Have a stable body weight in the past 1 month prior to screening
• Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

You may not qualify if:

• Have undergone gastric bypass or bariatric surgery
• Have a diagnosis of type 2 diabetes
• Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
• Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
• Have any lifetime history of a suicide attempt
• Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening
• Positive responses to selected items on the Columbia Suicide Severity Rating Scale (C-SSRS)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Links

• A Study to Measure Food and Calorie Consumption in Very Overweight Participants Using Tirzepatide

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; 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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: July 9, 2020
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: February 8, 2024
• Results First Posted: February 8, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)