NCT05134662

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes

Timeline
Completed

Started Feb 2022

Typical duration for phase_1 type-2-diabetes

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2023

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

November 15, 2021

Last Update Submit

June 18, 2025

Conditions

Type 2 Diabetes

Keywords

ObeseOverweightT2DM

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change from baseline in fasting serum glucose

    Baseline to Day 85

  • Change from baseline in hemoglobin A1c (HbA1c)

    Baseline to Day 85

Other Outcomes (3)

  • 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

Study Arms (4)

ALT-801 1.2 mg

EXPERIMENTAL

1.2 mg once weekly for 12 weeks

Drug: ALT-801

ALT-801 1.8 mg

EXPERIMENTAL

1.8 mg once weekly for 12 weeks

Drug: ALT-801

ALT-801 2.4 mg

EXPERIMENTAL

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

PLACEBO COMPARATOR

placebo once weekly for 12 weeks

Other: Placebo

Interventions

ALT-801DRUG

Injected subcutaneously (SC)

ALT-801 1.2 mgALT-801 1.8 mgALT-801 2.4 mg
PlaceboOTHER

Injected subcutaneously (SC)

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Altimmune CTM

Fort Myers, Florida, 33900, United States

Location

Altimmune CTM

Sarasota, Florida, 34230, United States

Location

Altimmune CTM

River Forest, Illinois, 60305, United States

Location

Altimmune CTM

Kansas City, Missouri, 64101, United States

Location

Altimmune CTM

Knoxville, Tennessee, 37922, United States

Location

Altimmune CTM

San Antonio, Texas, 78201, United States

Location

Altimmune CTM

Tomball, Texas, 77375, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityOverweight

Interventions

ALT-801

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • M. Scott Harris, MD

    Altimmune, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 26, 2021

Study Start

February 1, 2022

Primary Completion

February 3, 2023

Study Completion

March 9, 2023

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations

US(7)