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

Altimmune

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Other: Placebo; Drug: ALT-801

Study type: Interventional

Funder types: Industry

Identifiers

NCT05134662

ALT-801-104

Details and patient eligibility

About

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).

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 4 patient groups, including a placebo group

ALT-801 1.2 mg

Experimental group

Description:

1.2 mg once weekly for 12 weeks

Treatment:

Drug: ALT-801

ALT-801 1.8 mg

Experimental group

Description:

1.8 mg once weekly for 12 weeks

Treatment:

Drug: ALT-801

ALT-801 2.4 mg

Experimental group

Description:

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

Treatment:

Drug: ALT-801

Placebo

Placebo Comparator group

Description:

placebo once weekly for 12 weeks

Treatment:

Other: Placebo