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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-03-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

NCT01017302

Diabetes Mellitus Type 2

COMPLETED PHASE1

A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus

NCT06988553

Obesity or Overweight Type 2 Diabetes

COMPLETED PHASE1

Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus

NCT05268237

Diabete Type 2

RECRUITING PHASE1/PHASE2

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GLWL-01

NCT02377362

Diabetes Mellitus, Type 2

TERMINATED PHASE1

Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

NCT00817778

Type 2 Diabetes

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ALT-801 1.2 mg

1.2 mg once weekly for 12 weeks

Group Type EXPERIMENTAL

ALT-801

Intervention Type DRUG

Injected subcutaneously (SC)

ALT-801 1.8 mg

1.8 mg once weekly for 12 weeks

Group Type EXPERIMENTAL

ALT-801

Intervention Type DRUG

Injected subcutaneously (SC)

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

Group Type EXPERIMENTAL

ALT-801

Intervention Type DRUG

Injected subcutaneously (SC)

Placebo

placebo once weekly for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Injected subcutaneously (SC)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALT-801

Injected subcutaneously (SC)

Intervention Type DRUG

Placebo

Injected subcutaneously (SC)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No