DRUG
ALT-801
Injected subcutaneously (SC)
ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)
Status
Completed
Phase
Phase 1
Enrollment
55
Locations
7
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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).
Interventions
Treatment arms and agents.
OTHER
Placebo
Injected subcutaneously (SC)
Timeline
From registration to results.
First posted
Nov 26, 2021
Study start
Feb 1, 2022
Primary completion
Feb 3, 2023
Study completion
Mar 9, 2023
Results posted
Not reported
Registry updated
Jun 24, 2025
Outcomes
What the study measures.
Primary outcomes
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame · Up to Day 110
Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin
Time frame · 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)
Time frame · Baseline to Day 85
Secondary outcomes
Change from baseline in fasting serum glucose
Time frame · Baseline to Day 85
Change from baseline in hemoglobin A1c (HbA1c)
Time frame · Baseline to Day 85
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- 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: * 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 locations
7 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Altimmune CTM
Fort Myers, Florida, United States
Altimmune CTM
Sarasota, Florida, United States
Altimmune CTM
River Forest, Illinois, United States
Altimmune CTM
Kansas City, Missouri, United States
Altimmune CTM
Knoxville, Tennessee, United States
Altimmune CTM
San Antonio, Texas, United States
Altimmune CTM
Tomball, Texas, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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