Efficacy and Safety of ALT-801 in the Treatment of Obesity

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity/Overweight

In brief

This study will evaluate the efficacy and safety of ALT-801 once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity in patients with obesity/overweight.

Key facts

Study ID

NCT05295875

Run by

Altimmune, Inc.

People needed

391

Starts

2022-03-31

Expected to finish

2023-09-28

Last updated by the study team

2023-11-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent signed prior to entry into the study
• 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

You may not qualify if…

• Weight gain or loss > 5% in the 3 months prior to randomization or >10% in the 6 months prior to screening
• Diabetes and related conditions:
• History or clinical evidence of diabetes mellitus of any type, including Type 1, Type 2, or mature onset diabetes of the young (MODY)
• 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:
• Obesity induced by known genetic causes or endocrine disorders (eg, Cushing Syndrome, inadequately treated hypothyroidism, defined as thyroid-stimulating hormone [TSH] > 6 mIU/L)
• 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:
• History of acute or chronic pancreatitis within 1 year (365 days) before screening
• History of or acute significant gastrointestinal (GI) disorder (eg, peptic ulcers, severe gastroesophageal reflux disease [GERD],
• History of GI surgery, including cholecystectomy and antrectomy. Surgery for appendicitis and small bowel resection >20cm is acceptable.
• 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:
• Untreated depressive disorder, defined as a Patient Health Questionaire-9 (PHQ-9) score of ≥ 15 at screening
• 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
• Other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)

Where it is running

• 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

Full record on ClinicalTrials.gov

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