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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ALT-801

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Obese, Overweight, T2DM

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Altimmune CTM
Altimmune CTM
Altimmune CTM
Altimmune CTM
Altimmune CTM
Altimmune CTM
Altimmune CTM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

ALT-801 Dose Level 1

ALT-801 Dose Level 2

ALT-801 Dose Level 3

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

Change from baseline in fasting serum glucose

Change from baseline in hemoglobin A1c (HbA1c)

Full Information

NCT ID

NCT05134662

First Posted

November 15, 2021

Last Updated

August 9, 2023

Sponsor

Altimmune, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05134662

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

February 3, 2023 (Actual)

Study Completion Date

March 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Altimmune, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Obese, Overweight, T2DM

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALT-801 Dose Level 1

Arm Type

Experimental

Arm Title

ALT-801 Dose Level 2

Arm Type

Experimental

Arm Title

ALT-801 Dose Level 3

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ALT-801

Intervention Description

Injected subcutaneously (SC)

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Injected subcutaneously (SC)

Primary Outcome Measure Information:

Title

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

Time Frame

Up to Day 110

Title

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

Time Frame

Baseline to Day 85

Title

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 Outcome Measure Information:

Title

Change from baseline in fasting serum glucose

Time Frame

Baseline to Day 85

Title

Change from baseline in hemoglobin A1c (HbA1c)

Time Frame

Baseline to Day 85

Other Pre-specified Outcome Measures:

Title

Changes in quality of life questionnaires compared to baseline

Time Frame

Baseline to Day 85

Title

ALT-801 concentrations

Time Frame

Baseline to Day 110

Title

Change from baseline metformin concentrations

Time Frame

Baseline to Day 85

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Altimmune CTM

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33900

Country

United States

Facility Name

Altimmune CTM

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34230

Country

United States

Facility Name

Altimmune CTM

City

River Forest

State/Province

Illinois

ZIP/Postal Code

60305

Country

United States

Facility Name

Altimmune CTM

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64101

Country

United States

Facility Name

Altimmune CTM

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37922

Country

United States

Facility Name

Altimmune CTM

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78201

Country

United States

Facility Name

Altimmune CTM

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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