ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)

Type 2 Diabetes Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Tolerability, Pharmacodynamics and Pharmacokinetics of ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134662
• Other study ID #: ALT-801-104
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight
• Type 2 Diabetes

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