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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: ALT-801
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALT-801 Dose Level 1<br> | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>|
| Experimental: ALT-801 Dose Level 2<br> | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>|
| Experimental: ALT-801 Dose Level 3<br> | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Injected subcutaneously (SC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting serum glucose |  | Baseline to Day 85 | 
| Change from baseline in hemoglobin A1c (HbA1c) |  | Baseline to Day 85 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obese, Overweight, T2DM