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Obesity/OverweightPhase 2NCT05295875

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

A Phase 2 study testing ALT-801 in people with Obesity/Overweight, run by Altimmune, Inc. at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity/Overweight
What is being tested?
ALT-801
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
391 participants
Where
31 sitesUnited States
Study dates
31 Mar 2022to 28 Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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)

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Altimmune CTM

    Austin, Texas, 78701

  • Altimmune CTM

    Baton Rouge, Louisiana, 70801

  • Altimmune CTM

    Bellaire, Texas, 77401

  • Altimmune CTM

    Berlin, New Jersey, 08009

  • Altimmune CTM

    Birmingham, Alabama, 35020

  • Altimmune CTM

    Boca Raton, Florida, 33427

  • Altimmune CTM

    Butte, Montana, 59701

  • Altimmune CTM

    Cincinnati, Ohio, 45201

  • Altimmune CTM

    Clearwater, Florida, 33755

  • Altimmune CTM

    Evanston, Illinois, 60201

  • Altimmune CTM

    Fort Myers, Florida, 33900

  • Altimmune CTM

    Indianapolis, Indiana, 46201

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • Altimmune CTM

    Jacksonville, Florida, 32201

  • Altimmune CTM

    Kansas City, Missouri, 64101

  • Altimmune CTM

    Knoxville, Tennessee, 37901

  • Altimmune CTM

    Los Angeles, California, 90001

  • National Research Institute

    Los Angeles, California, 90057

  • Altimmune CTM

    Louisville, Kentucky, 40202

  • Altimmune CTM

    Mesa, Arizona, 85201

  • Altimmune CTM

    Montclair, California, 91763

  • Altimmune CTM

    New Orleans, Louisiana, 70119

  • Altimmune CTM

    New York, New York, 10001

  • Cornell University, Joan and Sanford Weill Medical College

    New York, New York, 10065

  • Altimmune CTM

    Philadelphia, Pennsylvania, 19092

  • Altimmune CTM

    Port Orange, Florida, 32123

  • Altimmune CTM

    San Antonio, Texas, 78201

  • Altimmune CTM

    Santa Barbara, California, 93101

  • Altimmune CTM

    Savannah, Georgia, 31411

  • Altimmune CTM

    St. George, Utah, 84770

  • Altimmune CTM

    Sunrise, Florida, 33319

Other trials in United States

About this study

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)

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.

Being tested
ALT-801, Placebo
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALT-801Drug

    Injected subcutaneously (SC)

  • PlaceboOther

    Injected subcutaneously (SC)

Study groups in NCT05295875
Study groupRoleWhat they receive
ALT-801 Dose Level 1ExperimentalNot described
Receives: Drug: ALT-801
ALT-801 Dose Level 2ExperimentalNot described
Receives: Drug: ALT-801
ALT-801 Dose Level 3ExperimentalNot described
Receives: Drug: ALT-801
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative change from baseline in body weight percentage

    Measured: Baseline to Week 48

Secondary outcomes (8)

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

    Measured: Baseline to Week 48

  2. Change from baseline in lipids

    Measured: Baseline to Week 48

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

    Measured: Baseline to Week 48

  4. Changes from baseline in Fasting Glucose

    Measured: Baseline to Week 48

  5. Changes from baseline in Hemoglobin A1c

    Measured: Baseline to Week 48

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

    Measured: Baseline to Week 48

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

    Measured: Baseline to Week 48

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

    Measured: Baseline to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start31 Mar 2022
  3. Primary completion28 Sep 2023
  4. Study completion28 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
391 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295875
Sponsor's protocol ID
ALT-801-211
Status last verified
Nov 2023
First submitted
7 Feb 2022
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALT-801 in people with Obesity/Overweight, run by Altimmune, Inc. at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change from baseline in body weight percentage (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295875.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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