Clinical trial NCT05295875: Efficacy and Safety of ALT-801 in the Treatment of Obesity
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity/Overweight
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-25
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Relative change from baseline in body weight percentage
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Percent proportion of subjects with weight loss of greater than or equal to 5%, 10%, and 15%
timeFrame: Baseline to Week 48
measure: Change from baseline in lipids
timeFrame: Baseline to Week 48
measure: The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline to Week 48
measure: Changes from baseline in Fasting Glucose
timeFrame: Baseline to Week 48
measure: Changes from baseline in Hemoglobin A1c
timeFrame: Baseline to Week 48
measure: Changes from baseline in Homeostatic Marker Assessment for Insulin Resistance (HOMA-IR)
timeFrame: Baseline to Week 48
measure: Changes from baseline in: a) Systolic blood pressure, b) Diastolic blood pressure
timeFrame: Baseline to Week 48
measure: Change from baseline in proportion of patients using antihypertensive medications
timeFrame: Baseline to Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Altimmune CTM
state: Alabama
city: Mesa
country: United States
facility: Altimmune CTM
state: Arizona
city: Los Angeles
country: United States
facility: Altimmune CTM
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Montclair
country: United States
facility: Altimmune CTM
state: California
city: Santa Barbara
country: United States
facility: Altimmune CTM
state: California
city: Boca Raton
country: United States
facility: Altimmune CTM
state: Florida
city: Clearwater
country: United States
facility: Altimmune CTM
state: Florida
city: Fort Myers
country: United States
facility: Altimmune CTM
state: Florida
city: Jacksonville
country: United States
facility: Altimmune CTM
state: Florida
city: Port Orange
country: United States
facility: Altimmune CTM
state: Florida
city: Sunrise
country: United States
facility: Altimmune CTM
state: Florida
city: Savannah
country: United States
facility: Altimmune CTM
state: Georgia
city: Evanston
country: United States
facility: Altimmune CTM
state: Illinois
city: Indianapolis
country: United States
facility: Altimmune CTM
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Louisville
country: United States
facility: Altimmune CTM
state: Kentucky
city: Baton Rouge
country: United States
facility: Altimmune CTM
state: Louisiana
city: New Orleans
country: United States
facility: Altimmune CTM
state: Louisiana
city: Kansas City
country: United States
facility: Altimmune CTM
state: Missouri
city: Butte
country: United States
facility: Altimmune CTM
state: Montana
city: Berlin
country: United States
facility: Altimmune CTM
state: New Jersey
city: New York
country: United States
facility: Altimmune CTM
state: New York
city: New York
country: United States
facility: Cornell University, Joan and Sanford Weill Medical College
state: New York
city: Cincinnati
country: United States
facility: Altimmune CTM
state: Ohio
city: Philadelphia
country: United States
facility: Altimmune CTM
state: Pennsylvania
city: Knoxville
country: United States
facility: Altimmune CTM
state: Tennessee
city: Austin
country: United States
facility: Altimmune CTM
state: Texas
city: Bellaire
country: United States
facility: Altimmune CTM
state: Texas
city: San Antonio
country: United States
facility: Altimmune CTM
state: Texas
city: Saint George
country: United States
facility: Altimmune CTM
state: Utah
Study officials:
affiliation: Altimmune, Inc.
name: Sarah K Browne, MD
role: STUDY_DIRECTOR
References: