Efficacy and Safety of ALT-801 in the Treatment of Obesity
NCT ID: NCT05295875
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
391 participants
INTERVENTIONAL
2022-03-31
2023-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ALT-801 Dose Level 1
ALT-801
Injected subcutaneously (SC)
ALT-801 Dose Level 2
ALT-801
Injected subcutaneously (SC)
ALT-801 Dose Level 3
ALT-801
Injected subcutaneously (SC)
Placebo
Placebo
Injected subcutaneously (SC)
Interventions
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ALT-801
Injected subcutaneously (SC)
Placebo
Injected subcutaneously (SC)
Eligibility Criteria
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Inclusion Criteria
* Male or female age 18 to 75 years, inclusive
* Body mass index (BMI) ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 combined with at least one obesity-related comorbidity
* At least one unsuccessful weight loss attempt per investigator judgement
* Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study
* 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
* Diabetes and related conditions:
1. History or clinical evidence of diabetes mellitus of any type, including Type 1, Type 2, or mature onset diabetes of the young (MODY)
2. HbA1c \> 6.5%, fasting glucose ≥ 126 mg/dL (6.9 mmol/L), and/or random glucose of ≥ 200 mg/dL (11.0mmol/L) at screening
* Obesity and related conditions:
1. Obesity induced by known genetic causes or endocrine disorders (eg, Cushing Syndrome, inadequately treated hypothyroidism, defined as thyroid-stimulating hormone \[TSH\] \> 6 mIU/L)
2. History of bariatric surgery or other surgical treatment for obesity (eg, gastric banding, gastric bypass), or planned surgery or surgical treatment during the study. Liposuction and/or abdominoplasty performed \>1 year before screening is allowed. Endoscopically placed intragastric balloons will be allowed if removed \> 1 year before screening.
* Gastrointestinal conditions:
1. History of acute or chronic pancreatitis within 1 year (365 days) before screening
2. History of or acute significant gastrointestinal (GI) disorder (eg, peptic ulcers, severe gastroesophageal reflux disease \[GERD\],
3. History of GI surgery, including cholecystectomy and antrectomy. Surgery for appendicitis and small bowel resection \>20cm is acceptable.
4. History of inflammatory bowel disease, celiac disease or any medical condition or surgery that could affect gastric emptying, stool frequency or stool consistency. (Irritable bowel syndrome is permitted provided that bowel frequency and consistency are normal off treatment.)
* Mental health conditions:
1. Untreated depressive disorder, defined as a Patient Health Questionaire-9 (PHQ-9) score of ≥ 15 at screening
2. Suicide ideation, defined as type 4 or 5 on the Columbia-Suicide Severity Rating Scale(C-SSRS) at screening, lifelong history of a suicide attempt, or suicidal behavior within 30 days before screening
3. Other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)
18 Years
75 Years
ALL
No
Sponsors
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Altimmune, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah K Browne, MD
Role: STUDY_DIRECTOR
Altimmune, Inc.
Locations
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Altimmune CTM
Birmingham, Alabama, United States
Altimmune CTM
Mesa, Arizona, United States
Altimmune CTM
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
Altimmune CTM
Montclair, California, United States
Altimmune CTM
Santa Barbara, California, United States
Altimmune CTM
Boca Raton, Florida, United States
Altimmune CTM
Clearwater, Florida, United States
Altimmune CTM
Fort Myers, Florida, United States
Altimmune CTM
Jacksonville, Florida, United States
Altimmune CTM
Port Orange, Florida, United States
Altimmune CTM
Sunrise, Florida, United States
Altimmune CTM
Savannah, Georgia, United States
Altimmune CTM
Evanston, Illinois, United States
Altimmune CTM
Indianapolis, Indiana, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
Altimmune CTM
Louisville, Kentucky, United States
Altimmune CTM
Baton Rouge, Louisiana, United States
Altimmune CTM
New Orleans, Louisiana, United States
Altimmune CTM
Kansas City, Missouri, United States
Altimmune CTM
Butte, Montana, United States
Altimmune CTM
Berlin, New Jersey, United States
Altimmune CTM
New York, New York, United States
Cornell University, Joan and Sanford Weill Medical College
New York, New York, United States
Altimmune CTM
Cincinnati, Ohio, United States
Altimmune CTM
Philadelphia, Pennsylvania, United States
Altimmune CTM
Knoxville, Tennessee, United States
Altimmune CTM
Austin, Texas, United States
Altimmune CTM
Bellaire, Texas, United States
Altimmune CTM
San Antonio, Texas, United States
Altimmune CTM
St. George, Utah, United States
Countries
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Other Identifiers
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ALT-801-211
Identifier Type: -
Identifier Source: org_study_id