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

Sponsor

Altimmune, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05134662

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: ALT-801 Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALT-801 Dose Level 1	Drug: ALT-801 Injected subcutaneously (SC)
Experimental: ALT-801 Dose Level 2	Drug: ALT-801 Injected subcutaneously (SC)
Experimental: ALT-801 Dose Level 3	Drug: ALT-801 Injected subcutaneously (SC)
Placebo Comparator: Placebo	Other: Placebo Injected subcutaneously (SC)

Outcome Measures

Primary Outcome Measures

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

Change from baseline in fasting serum glucose [Baseline to Day 85]
Change from baseline in hemoglobin A1c (HbA1c) [Baseline to Day 85]

Other Outcome Measures

Changes in quality of life questionnaires compared to baseline [Baseline to Day 85]
ALT-801 concentrations [Baseline to Day 110]
Change from baseline metformin concentrations [Baseline to Day 85]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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