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

NCT05295875
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Phase
Phase 2
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Recruitment status
Completed
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Participants
391
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Lead sponsor
Altimmune, Inc.
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Start date
2022-03-31
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Number of sites
31
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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.
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Short title
Efficacy and Safety of ALT-801 in the Treatment of Obesity
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2023-09-28
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First posted
2022-03-25
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Registry last updated
2023-11-29
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Primary completion date
2023-09-28
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Start date
2022-03-31
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Actual participants
391
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Participants
391
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
31
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Altimmune, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05295875
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ClinicalTrials.gov ID
NCT05295875
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Relative change from baseline in body weight percentage

    Timeframe: Baseline to Week 48

  1. Percent proportion of subjects with weight loss of greater than or equal to 5%, 10%, and 15%

    Timeframe: Baseline to Week 48

  2. Change from baseline in lipids

    Timeframe: Baseline to Week 48

  3. The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: Baseline to Week 48

  4. Changes from baseline in Fasting Glucose

    Timeframe: Baseline to Week 48

  5. Changes from baseline in Hemoglobin A1c

    Timeframe: Baseline to Week 48

  6. Changes from baseline in Homeostatic Marker Assessment for Insulin Resistance (HOMA-IR)

    Timeframe: Baseline to Week 48

  7. Changes from baseline in: a) Systolic blood pressure, b) Diastolic blood pressure

    Timeframe: Baseline to Week 48

  8. Change from baseline in proportion of patients using antihypertensive medications

    Timeframe: Baseline to Week 48

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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

  • 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)
Sources for eligibility
clinicaltrials.gov

  • Altimmune CTMBirmingham, United States
  • Altimmune CTMMesa, United States
  • Altimmune CTMLos Angeles, United States
  • National Research InstituteLos Angeles, United States
  • Altimmune CTMMontclair, United States
  • Altimmune CTMSanta Barbara, United States
  • Altimmune CTMBoca Raton, United States
  • Altimmune CTMClearwater, United States
  • Altimmune CTMFort Myers, United States
  • Altimmune CTMJacksonville, United States
  • Altimmune CTMPort Orange, United States
  • Altimmune CTMSunrise, United States
  • Altimmune CTMSavannah, United States
  • Altimmune CTMEvanston, United States
  • Altimmune CTMIndianapolis, United States
  • Midwest Institute for Clinical ResearchIndianapolis, United States
  • Altimmune CTMLouisville, United States
  • Altimmune CTMBaton Rouge, United States
  • Altimmune CTMNew Orleans, United States
  • Altimmune CTMKansas City, United States
  • Altimmune CTMButte, United States
  • Altimmune CTMBerlin, United States
  • Altimmune CTMNew York, United States
  • Cornell University, Joan and Sanford Weill Medical CollegeNew York, United States
  • Altimmune CTMCincinnati, United States

And 6 more, listed on the interactive page.

Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)