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Immunotherapy

ALT-801 for Type 2 Diabetes

Phase 1
Waitlist Available
Research Sponsored by Altimmune, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 110
Awards & highlights

Study Summary

This trial is testing a new drug, ALT-801, to see if it is safe and effective in obese people with type 2 diabetes. The trial will compare ALT-801 to a placebo to see if it has any effect on blood sugar levels.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 110
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 110 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin
Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2)
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Change from baseline in fasting serum glucose
Change from baseline in hemoglobin A1c (HbA1c)
Other outcome measures
ALT-801 concentrations
Change from baseline metformin concentrations
Changes in quality of life questionnaires compared to baseline

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ALT-801 Dose Level 3Experimental Treatment1 Intervention
Group II: ALT-801 Dose Level 2Experimental Treatment1 Intervention
Group III: ALT-801 Dose Level 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALT-801
2010
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

Altimmune, Inc.Lead Sponsor
16 Previous Clinical Trials
1,483 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in this clinical experiment?

"Unfortunately, recruitment for this trial has been completed. It was initially advertised on February 1st 2022 and the last update to its listing occurred October 11th 2022. Fortunately, if you are seeking other studies in your area there are 1726 trials presently recruiting individuals with type 2 diabetes mellitus as well as a single study searching for ALT-801 participants."

Answered by AI

Is this clinical trial open to applicants who are younger than seventy-five years of age?

"In order to be accepted into this trial, potential participants must not exceed the age of 65 and should have reached the legal age of consent."

Answered by AI

Are there any opportunities to participate in this trial at present?

"Sadly, this clinical trial appears to be no longer recruiting participants. According to information posted on clinicialtrials.gov, the first listing was published in February 1st 2022 and its last update happened October 11th of that same year. Although there are no more spots available for this particular study, a total of 1727 other trials are currently looking for patients around the world."

Answered by AI

What other explorations have been conducted surrounding the effects of ALT-801?

"At the present time, 1 clinical experiment is examining ALT-801 with 0 trials in the advanced Phase 3. The primary location for these tests is Kansas City, Missouri; however, there are also 7 other locations that have initiated studies of this drug."

Answered by AI

In how many facilities can participants access this trial?

"Presently, this medical trial is being conducted at 7 distinct sites. These locations consist of Sarasota, Knoxville and River Forest plus 4 additional areas. To reduce the burden on yourself if you choose to join, pick the clinic that's closest to your home."

Answered by AI

To whom is this trial accessible?

"In order to qualify, applicants must have type 2 diabetes mellitus and be within the age range of 18-65. This medical trial seeks 48 total participants."

Answered by AI

Is this an original research endeavor?

"Currently, there is just one clinical trial for ALT-801 running in 7 distinct cities across 1 nation. This study was initiated by Altimmune Inc., with the first iteration being conducted back in 2022 and has since seen 48 individuals complete Phase 1 drug approval. Since then, a total of 18329 trials have been finalized."

Answered by AI

What risks do individuals face when taking ALT-801?

"Our team at Power has rated ALT-801's safety to be a 1 since its clinical trial is only in the first phase. As such, there is limited evidence confirming both efficacy and security of this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)
2022. "ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05134662.
~17 spots leftby Apr 2025
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