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
Overview
- Phase
- Phase 1
- Intervention
- ALT-801
- Conditions
- Type 2 Diabetes
- Sponsor
- Altimmune, Inc.
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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).
Investigators
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 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
Arms & Interventions
ALT-801 1.2 mg
1.2 mg once weekly for 12 weeks
Intervention: ALT-801
ALT-801 1.8 mg
1.8 mg once weekly for 12 weeks
Intervention: ALT-801
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
Intervention: ALT-801
Placebo
placebo once weekly for 12 weeks
Intervention: Placebo
Outcomes
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 hemoglobin A1c (HbA1c)(Baseline to Day 85)
- Change from baseline in fasting serum glucose(Baseline to Day 85)