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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05134662
Other study ID # ALT-801-104
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 1, 2022
Est. completion date March 9, 2023

Study information

Verified date August 2023
Source Altimmune, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALT-801 and its effects on glucose control in overweight and obese subjects with type 2 diabetes mellitus (T2DM).


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date March 9, 2023
Est. primary completion date February 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Written informed consent signed prior to the performance of any study procedures - Male or female volunteers, age 18 to 65 years, inclusive - Overweight to obese (BMI 28.0 - 40.0 kg/m2) - Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination of (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy - Female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control Exclusion Criteria: - Type 1 diabetes mellitus (DM) and/or insulin-dependent T2DM, or uncontrolled T2DM defined as hemoglobin A1c (HbA1c) = 9.5% or C-peptide = 8 ng/mL - History of acute or chronic pancreatitis or hypersensitivity reaction to GLP-1 analogues

Study Design


Intervention

Drug:
ALT-801
Injected subcutaneously (SC)
Other:
Placebo
Injected subcutaneously (SC)

Locations

Country Name City State
United States Altimmune CTM Fort Myers Florida
United States Altimmune CTM Kansas City Missouri
United States Altimmune CTM Knoxville Tennessee
United States Altimmune CTM River Forest Illinois
United States Altimmune CTM San Antonio Texas
United States Altimmune CTM Sarasota Florida
United States Altimmune CTM Tomball Texas

Sponsors (1)

Lead Sponsor Collaborator
Altimmune, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in quality of life questionnaires compared to baseline Baseline to Day 85
Other ALT-801 concentrations Baseline to Day 110
Other Change from baseline metformin concentrations Baseline to Day 85
Primary The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) Up to Day 110
Primary Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin Baseline to Day 85
Primary Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2) Baseline to Day 85
Secondary Change from baseline in fasting serum glucose Baseline to Day 85
Secondary Change from baseline in hemoglobin A1c (HbA1c) Baseline to Day 85
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