Type 2 DiabetesPhase 1NCT05134662
ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study testing ALT-801 in people with Type 2 Diabetes, run by Altimmune, Inc. at 7 sites in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALT-801 and its effects on glucose control in overweight and obese subjects with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- 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
- 55 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Feb 2022to 9 Mar 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent signed prior to the performance of any study procedures
- Male or female volunteers, age 18 to 65 years, inclusive
- Overweight to obese (BMI >/=28.0 kg/m2)
- Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination of (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy
- 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
- Type 1 diabetes mellitus (DM) and/or insulin-dependent T2DM, or uncontrolled T2DM defined as hemoglobin A1c (HbA1c) ≥ 9.5% or C-peptide ≤ 8 ng/mL
- History of acute or chronic pancreatitis or hypersensitivity reaction to GLP-1 analogues
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Altimmune CTM
Fort Myers, Florida, 33900
Altimmune CTM
Kansas City, Missouri, 64101
Altimmune CTM
Knoxville, Tennessee, 37922
Altimmune CTM
River Forest, Illinois, 60305
Altimmune CTM
San Antonio, Texas, 78201
Altimmune CTM
Sarasota, Florida, 34230
Altimmune CTM
Tomball, Texas, 77375
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Tolerability, Pharmacodynamics and Pharmacokinetics of ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus
This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALT-801 and its effects on glucose control in overweight and obese subjects with type 2 diabetes mellitus (T2DM).
- Conditions
- Type 2 Diabetes
- Being tested
- ALT-801, Placebo
- Keywords
- Obese, Overweight, T2DM
- Medical subject headings
- Diabetes Mellitus, Type 2, 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 group | Role | What they receive |
|---|---|---|
| ALT-801 1.2 mg | Experimental | 1.2 mg once weekly for 12 weeks Receives: Drug: ALT-801 |
| ALT-801 1.8 mg | Experimental | 1.8 mg once weekly for 12 weeks Receives: Drug: ALT-801 |
| ALT-801 2.4 mg | Experimental | 0.6 mg at Week 1, 1.2 mg at Week 2, 1.8 mg once weekly for 2 weeks (Weeks 3 and 4), and 2.4 mg once weekly for Weeks 5 through 12 Receives: Drug: ALT-801 |
| Placebo | Placebo comparator | placebo 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: Up to Day 110
Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin
Measured: Baseline to Day 85
Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2)
Measured: Baseline to Day 85
Secondary outcomes (2)
Change from baseline in fasting serum glucose
Measured: Baseline to Day 85
Change from baseline in hemoglobin A1c (HbA1c)
Measured: Baseline to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Feb 2022
- Primary completion3 Feb 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M. Scott Harris, MD, Study director, Altimmune, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134662
- Sponsor's protocol ID
- ALT-801-104
- Status last verified
- Jun 2025
- First submitted
- 15 Nov 2021
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Tolerability, Pharmacodynamics and Pharmacokinetics of ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05134662
- Acronym / sponsor ID
- ALT-801-104
- Conditions
- Type 2 Diabetes
- Keywords
- Obese, Overweight, T2DM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 26 Nov 2021 (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 is a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALT-801 and its effects on glucose control in overweight and obese subjects with type 2 diabetes mellitus (T2DM).
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 1.2 mg | Experimental | Drug: ALT-8011.2 mg once weekly for 12 weeks |
| ALT-801 1.8 mg | Experimental | Drug: ALT-8011.8 mg once weekly for 12 weeks |
| ALT-801 2.4 mg | Experimental | Drug: ALT-8010.6 mg at Week 1, 1.2 mg at Week 2, 1.8 mg once weekly for 2 weeks (Weeks 3 and 4), and 2.4 mg once weekly for Weeks 5 through 12 |
| Placebo | Placebo comparator | Other: Placeboplacebo once weekly for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent signed prior to the performance of any study procedures
- Male or female volunteers, age 18 to 65 years, inclusive
- Overweight to obese (BMI >/=28.0 kg/m2)
- Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination of (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy
- 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
Key exclusion criteria (2 listed)
- Type 1 diabetes mellitus (DM) and/or insulin-dependent T2DM, or uncontrolled T2DM defined as hemoglobin A1c (HbA1c) ≥ 9.5% or C-peptide ≤ 8 ng/mL
- History of acute or chronic pancreatitis or hypersensitivity reaction to GLP-1 analogues
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-801Injected subcutaneously (SC) | Drug | ALT-801 1.2 mg, ALT-801 1.8 mg, ALT-801 2.4 mg |
| PlaceboInjected subcutaneously (SC) | Other | Placebo |
Primary outcome
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 110
Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin
Time frame: Baseline to Day 85
Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2)
Time frame: Baseline to Day 85
2 secondary outcomes
Change from baseline in fasting serum glucose
Time frame: Baseline to Day 85
Change from baseline in hemoglobin A1c (HbA1c)
Time frame: Baseline to Day 85
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.
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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.
M. Scott Harris, MD study director
Altimmune, Inc.
7 sites 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 Type 2 Diabetes, run by Altimmune, Inc. at 7 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 5 inclusion and 2 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 7 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 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: Up to Day 110). The study lists 3 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.