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

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

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: ALT-801; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33900
      • Altimmune CTM
    • Sarasota, Florida, United States, 34230
      • Altimmune CTM
  • Illinois
    • River Forest, Illinois, United States, 60305
      • Altimmune CTM
  • Missouri
    • Kansas City, Missouri, United States, 64101
      • Altimmune CTM
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Altimmune CTM
  • Texas
    • San Antonio, Texas, United States, 78201
      • Altimmune CTM
    • Tomball, Texas, United States, 77375
      • Altimmune CTM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALT-801 1.2 mg; 1.2 mg once weekly for 12 weeks	Drug: ALT-801; Injected subcutaneously (SC)
Experimental: ALT-801 1.8 mg; 1.8 mg once weekly for 12 weeks	Drug: ALT-801; Injected subcutaneously (SC)
Experimental: ALT-801 2.4 mg; 0.6 mg at Week 1, 1.2 mg at Week 2, 1.8 mg once weekly for 2 weeks (Weeks 3 and 4), and 2.4 mg once weekly for Weeks 5 through 12	Drug: ALT-801; Injected subcutaneously (SC)
Placebo Comparator: Placebo; placebo once weekly for 12 weeks	Other: Placebo; Injected subcutaneously (SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Altimmune, Inc.
• Investigators: Study Director: M. Scott Harris, MD, Altimmune, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Overweight; Obese; T2DM
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: ALT-801-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No