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Trial record 1 of 16 for:    altimmune
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Efficacy and Safety of ALT-801 in the Treatment of Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05295875
Recruitment Status : Active, not recruiting
First Posted : March 25, 2022
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity/Overweight Drug: ALT-801 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled and Parallel Group 48-Week Study to Evaluate the Efficacy and Safety of ALT-801 in the Treatment of Obesity (MOMENTUM Trial)
Actual Study Start Date : March 31, 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : September 2023

Arm Intervention/treatment
Experimental: ALT-801 Dose Level 1 Drug: ALT-801
Injected subcutaneously (SC)

Experimental: ALT-801 Dose Level 2 Drug: ALT-801
Injected subcutaneously (SC)

Experimental: ALT-801 Dose Level 3 Drug: ALT-801
Injected subcutaneously (SC)

Placebo Comparator: Placebo Other: Placebo
Injected subcutaneously (SC)




Primary Outcome Measures :
  1. Relative change from baseline in body weight percentage [ Time Frame: Baseline to Week 48 ]

Secondary Outcome Measures :
  1. Percent proportion of subjects with weight loss of greater than or equal to 5%, 10%, and 15% [ Time Frame: Baseline to Week 48 ]
  2. Change from baseline in lipids [ Time Frame: Baseline to Week 48 ]
  3. The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline to Week 48 ]
  4. Changes from baseline in Fasting Glucose [ Time Frame: Baseline to Week 48 ]
  5. Changes from baseline in Hemoglobin A1c [ Time Frame: Baseline to Week 48 ]
  6. Changes from baseline in Homeostatic Marker Assessment for Insulin Resistance (HOMA-IR) [ Time Frame: Baseline to Week 48 ]
  7. Changes from baseline in: a) Systolic blood pressure, b) Diastolic blood pressure [ Time Frame: Baseline to Week 48 ]
  8. Change from baseline in proportion of patients using antihypertensive medications [ Time Frame: Baseline to Week 48 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05295875


Locations
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United States, Alabama
Altimmune CTM
Birmingham, Alabama, United States, 35020
United States, Arizona
Altimmune CTM
Mesa, Arizona, United States, 85201
United States, California
Altimmune CTM
Los Angeles, California, United States, 90001
National Research Institute
Los Angeles, California, United States, 90057
Altimmune CTM
Montclair, California, United States, 91763
Altimmune CTM
Santa Barbara, California, United States, 93101
United States, Florida
Altimmune CTM
Boca Raton, Florida, United States, 33427
Altimmune CTM
Clearwater, Florida, United States, 33755
Altimmune CTM
Fort Myers, Florida, United States, 33900
Altimmune CTM
Jacksonville, Florida, United States, 32201
Altimmune CTM
Port Orange, Florida, United States, 32123
Altimmune CTM
Sunrise, Florida, United States, 33319
United States, Georgia
Altimmune CTM
Savannah, Georgia, United States, 31411
United States, Illinois
Altimmune CTM
Evanston, Illinois, United States, 60201
United States, Indiana
Altimmune CTM
Indianapolis, Indiana, United States, 46201
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Altimmune CTM
Louisville, Kentucky, United States, 40202
United States, Louisiana
Altimmune CTM
Baton Rouge, Louisiana, United States, 70801
Altimmune CTM
New Orleans, Louisiana, United States, 70119
United States, Missouri
Altimmune CTM
Kansas City, Missouri, United States, 64101
United States, Montana
Altimmune CTM
Butte, Montana, United States, 59701
United States, New Jersey
Altimmune CTM
Berlin, New Jersey, United States, 08009
United States, New York
Altimmune CTM
New York, New York, United States, 10001
Cornell University, Joan and Sanford Weill Medical College
New York, New York, United States, 10065
United States, Ohio
Altimmune CTM
Cincinnati, Ohio, United States, 45201
United States, Pennsylvania
Altimmune CTM
Philadelphia, Pennsylvania, United States, 19092
United States, Tennessee
Altimmune CTM
Knoxville, Tennessee, United States, 37901
United States, Texas
Altimmune CTM
Austin, Texas, United States, 78701
Altimmune CTM
Bellaire, Texas, United States, 77401
Altimmune CTM
San Antonio, Texas, United States, 78201
United States, Utah
Altimmune CTM
Saint George, Utah, United States, 84770
Sponsors and Collaborators
Altimmune, Inc.
Investigators
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Study Director: Sarah K Browne, MD Altimmune, Inc.
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Responsible Party: Altimmune, Inc.
ClinicalTrials.gov Identifier: NCT05295875    
Other Study ID Numbers: ALT-801-211
First Posted: March 25, 2022    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight