Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects

NCT03041792 | Completed Phase 1 Results FDA Drug

• 1 other identifier: A9001498
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, double blind, placebo controlled, 2 arm, parallel group, methodology study to assess the effect of 6 weeks of liraglutide administration on food intake in obese subjects.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5

  The mean energy intake was collected to assess the effect of liraglutide on food intake in non-diabetic, obese participants. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Mean energy intakes at Visit 4 was defined as the mean values of the measurements at Study Day 20 and 21. Same definition applies to Visit 5 (Study Day 41 and 42). Baseline was defined as the mean of Visit 3 (Study Day -1 and 0).

  Visit 3, Visit 4 and Visit 5

Secondary Outcomes (8)

• Number of Participants With Vital Signs Data Meeting Categorical Criteria

  Baseline (Visit 3) up to Visit 6 (Study Day 53)

• Number of Participants With Treatment-Emergent Adverse Events (All-Causality)

  Baseline (Visit 3) up to 31 days post last dose (75 days)

• Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)

  Baseline (Visit 3) up to Visit 6 (Study Day 53)

• Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

  Baseline (Visit 3) up to Visit 6 (Study Day 53)

• Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5

  Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)

Study Arms (2)

Active

EXPERIMENTAL

Liraglutide

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

Placebo comparator

Other: Placebo

Interventions

Liraglutide DRUG

Liraglutide

Active

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and female subjects;
• Body Mass Index 30-40 kg/m2;

You may not qualify if:

• Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

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; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: February 1, 2017
• First Posted: February 3, 2017
• Study Start: February 20, 2017
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: July 26, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)