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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: ALT-801; Other: Placebo

• Registration Number: NCT05134662
• Lead Sponsor: Altimmune, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-26
• Study Start: 2022-02-01
• Primary Completion: 2023-02-03
• Study Completion: 2023-03-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALT-801 Dose Level 1	ALT-801	-
ALT-801 Dose Level 2	ALT-801	-
ALT-801 Dose Level 3	ALT-801	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)	Up to Day 110
Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin	Baseline to Day 85
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 Outcome Measures

Name	Time	Method
Change from baseline in hemoglobin A1c (HbA1c)	Baseline to Day 85
Change from baseline in fasting serum glucose	Baseline to Day 85

Trial Locations

Locations (1)

Altimmune CTM; 🇺🇸 Tomball, Texas, United States