ObesityPhase 1NCT04561245
ALT-801 (Pemvidutide) in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability
A Phase 1 study testing ALT-801 in people with Obesity and Nonalcoholic Steatohepatitis, run by Altimmune, Inc. at 1 site in Australia.
Trial summary
This study was a FIH, Phase 1, randomized, double-blind, placebo-controlled, 2-part single-ascending dose (SAD) and multiple-ascending dose (MAD) study of ALT-801 (pemvidutide) in healthy overweight and obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Nonalcoholic Steatohepatitis
- 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
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Nov 2020to 29 Oct 2021
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female healthy volunteers, age 18 to 60 years, inclusive
- Overweight to obese (BMI 25.0 - 40.0 kg/m2)
- MRI-PDFF≥ 10% (Part 2 only)
- Non-smokers or ex-smokers (must have ceased smoking > 1 months prior to screening visit)
- Subjects must otherwise be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study medication
- Ability and willingness to attend the necessary visits to the study center
- Written informed consent signed prior to entry into the study
Who cannot join
- Women who are pregnant or breastfeeding
- History of pancreatitis
- History of or acute significant GI disorder
- History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5%
- History of clinically significant endocrine (eg, hypothyroidism), neurological, GI, cardiovascular (except controlled hypertension and hypercholesterolemia), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of neoplastic disease, or personal or family history of multiple endocrine neoplasia or medullary cancer of the thyroid, with the following exceptions:
Show all 14Show fewer
- Adequately treated non-melanomatous skin carcinoma
- Female with a history of benign cervical neoplasia if the subject has been compliant with surveillance and treatment as recommended by her physician
- Blood pressure > 150/90 mmHg or heart rate > 100 beats per minute at screening and at Day -1
- Clinically significant laboratory abnormalities including:
- Impaired renal function (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73m2) as estimated using the MDRD equation at screening:
- GFR (mL/min/1.73 m²) = 175 × (SCr/88.4)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American) (SI units), where SCr is standardized serum creatinine in SI units (µmol/L) and age is in years
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values > 2 × upper normal limits
- Calcitonin > 50 ng/L - Excessive alcohol consumption defined as >21 alcohol units per week for males and as >14 alcohol units per week for females (where 1 unit = half pint of beer, 25 mL of 40% spirit, or 125 mL of wine)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ALT-801 in Healthy Overweight and Obese Volunteers
This study was a FIH, Phase 1, randomized, double-blind, placebo-controlled, 2-part single-ascending dose (SAD) and multiple-ascending dose (MAD) study of ALT-801 (pemvidutide) in healthy overweight and obese subjects.
The purpose of the study was to assess the safety and tolerability in healthy overweight and obese volunteers administered single or multiple repeated doses of ALT-801 (pemvidutide).
Read the detailed description
This study had 2 parts. Part 1 involved single dose cohorts of ALT-801 (pemvidutide) or placebo taken as a subcutaneous (SC) injection and was approximately 36 days in duration. Part 2 involved multiple dose cohorts of ALT-801 (pemvidutide) or placebo taken once a week for 12 weeks as a SC injection and was approximately 116 days in duration. Each participant enrolled in only one part.
- Conditions
- Obesity, Nonalcoholic Steatohepatitis
- Being tested
- ALT-801, Placebo
- Keywords
- NASH, Obesity
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALT-801Drug
Also called Pemvidutide
Injected subcutaneously (SC)
PlaceboOther
Injected subcutaneously (SC)
| Study group | Role | What they receive |
|---|---|---|
| ALT-801 (Part 1) | Experimental | Single ascending dose (SAD) cohorts of ALT-801 Receives: Drug: ALT-801 |
| Placebo (Part 1) | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
| ALT-801 (Part 2) | Experimental | Multiple ascending dose (MAD) cohorts of ALT-801 administered once weekly for 12 weeks Receives: Drug: ALT-801 |
| Placebo (Part 2) | Placebo comparator | Placebo administered once weekly for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Measured: Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42
Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801
Measured: Baseline, Day 26
Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801
Measured: Baseline to Day 26
Change in body weight
Measured: Baseline to Week 6
Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start10 Nov 2020
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Altimmune Chief Medical Officer, Study director, Altimmune, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561245
- Sponsor's protocol ID
- ALT-801-101
- Other IDs
- Pemvidutide
- Status last verified
- Jun 2025
- First submitted
- 16 Sep 2020
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ALT-801 in Healthy Overweight and Obese Volunteers
- ClinicalTrials.gov ID
- NCT04561245
- Acronym / sponsor ID
- ALT-801-101
- Conditions
- Obesity, Nonalcoholic Steatohepatitis
- Keywords
- NASH, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a FIH, Phase 1, randomized, double-blind, placebo-controlled, 2-part single-ascending dose (SAD) and multiple-ascending dose (MAD) study of ALT-801 (pemvidutide) in healthy overweight and obese subjects.
The purpose of the study was to assess the safety and tolerability in healthy overweight and obese volunteers administered single or multiple repeated doses of ALT-801 (pemvidutide).
Detailed description
This study had 2 parts. Part 1 involved single dose cohorts of ALT-801 (pemvidutide) or placebo taken as a subcutaneous (SC) injection and was approximately 36 days in duration. Part 2 involved multiple dose cohorts of ALT-801 (pemvidutide) or placebo taken once a week for 12 weeks as a SC injection and was approximately 116 days in duration. Each participant enrolled in only one part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALT-801 (Part 1) | Experimental | Drug: ALT-801Single ascending dose (SAD) cohorts of ALT-801 |
| Placebo (Part 1) | Placebo comparator | Other: PlaceboSingle dose of placebo |
| ALT-801 (Part 2) | Experimental | Drug: ALT-801Multiple ascending dose (MAD) cohorts of ALT-801 administered once weekly for 12 weeks |
| Placebo (Part 2) | Placebo comparator | Other: PlaceboPlacebo administered once weekly for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female healthy volunteers, age 18 to 60 years, inclusive
- Overweight to obese (BMI 25.0 - 40.0 kg/m2)
- MRI-PDFF≥ 10% (Part 2 only)
- Non-smokers or ex-smokers (must have ceased smoking > 1 months prior to screening visit)
- Subjects must otherwise be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study medication
Key exclusion criteria (14 listed)
- Women who are pregnant or breastfeeding
- History of pancreatitis
- History of or acute significant GI disorder
- History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5%
- History of clinically significant endocrine (eg, hypothyroidism), neurological, GI, cardiovascular (except controlled hypertension and hypercholesterolemia), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALT-801Also: PemvidutideInjected subcutaneously (SC) | Drug | ALT-801 (Part 1), ALT-801 (Part 2) |
| PlaceboInjected subcutaneously (SC) | Other | Placebo (Part 1), Placebo (Part 2) |
Primary outcome
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame: Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42
Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801
Time frame: Baseline, Day 26
Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801
Time frame: Baseline to Day 26
Change in body weight
Time frame: Baseline to Week 6
Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)
Time frame: Baseline to Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Altimmune Chief Medical Officer study director
Altimmune, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALT-801 in people with Obesity and Nonalcoholic Steatohepatitis, run by Altimmune, Inc. at 1 site in Australia.
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 7 inclusion and 14 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) (time frame: Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2025.