Skip to main content
OpenTrials
Completed

NCT Number: NCT05134662

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altimmune CTM, Fort Myers, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALT-801

Drug

Injected subcutaneously (SC)

Placebo

Other

Injected subcutaneously (SC)

Primary outcomes

  1. The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 110

  2. Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin

    Time frame: Baseline to Day 85

  3. Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2)

    Time frame: Baseline to Day 85

Secondary outcomes

  1. Change from baseline in fasting serum glucose

    Time frame: Baseline to Day 85

  2. Change from baseline in hemoglobin A1c (HbA1c)

    Time frame: Baseline to Day 85

Other outcomes

  1. Changes in quality of life questionnaires compared to baseline

    Time frame: Baseline to Day 85

  2. ALT-801 concentrations

    Time frame: Baseline to Day 110

  3. Change from baseline metformin concentrations

    Time frame: Baseline to Day 85

Sponsors and collaborators

Lead sponsor

Altimmune, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 26, 2021
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.