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ALT-801 for Obesity/Overweight

Phase 2
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 baseline to week 48
Awards & highlights

Study Summary

This trial will test if a new drug, ALT-801, can help people with obesity lose weight when combined with a reduced-calorie diet and increased physical activity.

Eligible Conditions
  • Obesity/Overweight

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative change from baseline in body weight percentage
Secondary outcome measures
Change from baseline in lipids
Change from baseline in proportion of patients using antihypertensive medications
Changes from baseline in Fasting Glucose
+5 more

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
1,147 Total Patients Enrolled
Sarah K Browne, MDStudy DirectorAltimmune, Inc.
2 Previous Clinical Trials
159 Total Patients Enrolled

Frequently Asked Questions

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

Does this research project have an age limit? If so, what is it?

"This particular study is only for patients aged 18-75. However, there are a total of 231 clinical trials ongoing for individuals under the age of 18 and 730 for senior citizens who are 65 years or older."

Answered by AI

Which type of patient is most likely to respond well to this treatment?

"Researchers conducting this study are looking for 320 patients that suffer from obesity, defined as a Body Mass Index (BMI) of 30 kg/m2 or higher. The trial has the following inclusion criteria: participants must be between 18 and 75 years old, have attempted and failed to lose weight in the past, be willing to commit to the required lifestyle changes for the duration of the study, and use effective birth control if they are female and of childbearing potential."

Answered by AI

Are volunteers currently being enrolled in this research study?

"This particular trial is not enrolling patients right now but that may change in the future. According to clinicaltrials.gov, this study was first posted on March 31st, 2022 and last updated September 7th, 2022. There are 1193 other trials currently looking for participants."

Answered by AI

What is the current status of ALT-801's approval process by the FDA?

"Although Phase 2 trials offer preliminary evidence of safety, there is no data yet supporting the efficacy of ALT-801. Consequently, our team has given it a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Louisiana
Ohio
Other
How old are they?
18 - 65
What site did they apply to?
Altimmune CTM
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

I am overwound need to lose weight.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of ALT-801 in the Treatment of Obesity
2022. "Efficacy and Safety of ALT-801 in the Treatment of Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05295875.
~127 spots leftby May 2025
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