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

November 27, 2023 updated by: Altimmune, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
391

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35020
        • Altimmune CTM
    • Arizona
      • Mesa, Arizona, United States, 85201
        • Altimmune CTM
    • California
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • Los Angeles, California, United States, 90001
        • Altimmune CTM
      • Montclair, California, United States, 91763
        • Altimmune CTM
      • Santa Barbara, California, United States, 93101
        • Altimmune CTM
    • Florida
      • 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
        • Altimmune CTM
    • Georgia
      • Savannah, Georgia, United States, 31411
        • Altimmune CTM
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Altimmune CTM
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Midwest Institute for Clinical Research
      • Indianapolis, Indiana, United States, 46201
        • Altimmune CTM
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Altimmune CTM
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70801
        • Altimmune CTM
      • New Orleans, Louisiana, United States, 70119
        • Altimmune CTM
    • Missouri
      • Kansas City, Missouri, United States, 64101
        • Altimmune CTM
    • Montana
      • Butte, Montana, United States, 59701
        • Altimmune CTM
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Altimmune CTM
    • New York
      • New York, New York, United States, 10001
        • Altimmune CTM
      • New York, New York, United States, 10065
        • Cornell University, Joan and Sanford Weill Medical College
    • Ohio
      • Cincinnati, Ohio, United States, 45201
        • Altimmune CTM
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19092
        • Altimmune CTM
    • Tennessee
      • Knoxville, Tennessee, United States, 37901
        • Altimmune CTM
    • Texas
      • Austin, Texas, United States, 78701
        • Altimmune CTM
      • Bellaire, Texas, United States, 77401
        • Altimmune CTM
      • San Antonio, Texas, United States, 78201
        • Altimmune CTM
    • Utah
      • Saint George, Utah, United States, 84770
        • Altimmune CTM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Injected subcutaneously (SC)
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Relative change from baseline in body weight percentage
Time Frame: Baseline to Week 48
Baseline to Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percent proportion of subjects with weight loss of greater than or equal to 5%, 10%, and 15%
Time Frame: Baseline to Week 48
Baseline to Week 48
Change from baseline in lipids
Time Frame: Baseline to Week 48
Baseline to Week 48
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline to Week 48
Baseline to Week 48
Changes from baseline in Fasting Glucose
Time Frame: Baseline to Week 48
Baseline to Week 48
Changes from baseline in Hemoglobin A1c
Time Frame: Baseline to Week 48
Baseline to Week 48
Changes from baseline in Homeostatic Marker Assessment for Insulin Resistance (HOMA-IR)
Time Frame: Baseline to Week 48
Baseline to Week 48
Changes from baseline in: a) Systolic blood pressure, b) Diastolic blood pressure
Time Frame: Baseline to Week 48
Baseline to Week 48
Change from baseline in proportion of patients using antihypertensive medications
Time Frame: Baseline to Week 48
Baseline to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Altimmune, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sarah K Browne, MD, Altimmune, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALT-801-211

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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