Overview

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

Status:
Not yet recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Altimmune, Inc.
Criteria
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