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CompletedNCT05134662Updated Jun 24, 2025

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

A Phase 1 interventional study of ALT-801 and Placebo in Type 2 Diabetes, sponsored by Altimmune, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Altimmune, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Obese
  • Overweight
  • T2DM
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    ALT-801 1.2 mg

    1.2 mg once weekly for 12 weeks

    Drug: ALT-801

  • Experimental
    ALT-801 1.8 mg

    1.8 mg once weekly for 12 weeks

    Drug: ALT-801

  • 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

  • Placebo comparator
    Placebo

    placebo once weekly for 12 weeks

    Other: Placebo

Interventions

  • DrugALT-801

    Injected subcutaneously (SC)

  • OtherPlacebo

    Injected subcutaneously (SC)

05

What researchers measure

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

06

Study locations

7 sites
  • Altimmune CTM
    Fort Myers, Florida 33900, United States
  • Altimmune CTM
    Sarasota, Florida 34230, United States
  • Altimmune CTM
    River Forest, Illinois 60305, United States
  • Altimmune CTM
    Kansas City, Missouri 64101, United States
  • Altimmune CTM
    Knoxville, Tennessee 37922, United States
  • Altimmune CTM
    San Antonio, Texas 78201, United States
  • Altimmune CTM
    Tomball, Texas 77375, United States
07

Registry details

Key details

Study ID
NCT05134662
Lead sponsor
Altimmune, Inc.
Responsible party
Sponsor
First posted
Nov 26, 2021
Start date
Feb 1, 2022
Primary completion
Feb 3, 2023
Completion
Mar 9, 2023
Last update
Jun 24, 2025

Study contacts

M. Scott Harris, MD
study director · Altimmune, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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