Clinical trial NCT05134662: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Obese
Overweight
T2DM
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 110
measure: Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin
timeFrame: Baseline to Day 85
measure: Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2)
timeFrame: Baseline to Day 85
Secondary outcomes:
measure: Change from baseline in fasting serum glucose
timeFrame: Baseline to Day 85
measure: Change from baseline in hemoglobin A1c (HbA1c)
timeFrame: Baseline to Day 85
Other outcomes:
measure: Changes in quality of life questionnaires compared to baseline
timeFrame: Baseline to Day 85
measure: ALT-801 concentrations
timeFrame: Baseline to Day 110
measure: Change from baseline metformin concentrations
timeFrame: Baseline to Day 85
Locations:
city: Fort Myers
country: United States
facility: Altimmune CTM
state: Florida
city: Sarasota
country: United States
facility: Altimmune CTM
state: Florida
city: River Forest
country: United States
facility: Altimmune CTM
state: Illinois
city: Kansas City
country: United States
facility: Altimmune CTM
state: Missouri
city: Knoxville
country: United States
facility: Altimmune CTM
state: Tennessee
city: San Antonio
country: United States
facility: Altimmune CTM
state: Texas
city: Tomball
country: United States
facility: Altimmune CTM
state: Texas
Study officials:
References: