Overweight and ObesityPhase 1NCT04855565
ALY688-SR in Generally Healthy Overweight or Obese Adults
A Phase 1 study testing ALY688-SR in people with Overweight and Obesity, run by Allysta Pharmaceutical at 1 site in Australia.
Trial summary
First in human study of ALY688-SR administered as a subcutaneous injection Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- ALY688-SR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- 19 May 2021to 3 Aug 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
- Body mass index 24 to 35 kg/m2 Body weight 60 to 120 kg,
Who cannot join
- Confirmed diabetes on treatment Inadequately managed hypertension Poorly controlled hypercholesterolemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of ALY688-SR in Generally Healthy Overweight or Obese Adults
First in human study of ALY688-SR administered as a subcutaneous injection
Read the detailed description
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ALY688-SR compared to placebo administered as a subcutaneous injection.
- Conditions
- Overweight and Obesity
- Being tested
- ALY688-SR
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALY688-SRDrug
single dose subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| ALY688-SR | Active comparator | single dose subcutaneous injection Receives: Drug: ALY688-SR |
| Matching placebo for ALY688-SR | Placebo comparator | single dose subcutaneous injection Receives: Drug: ALY688-SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between pre- and post-intervention safety and tolerability assessments
Incidence of Treatment-Emergent Adverse Events as assessed by lab evaluations, ECG, vital signs and physical examinations
Measured: baseline, pre-intervention through study completion at 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start19 May 2021
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Why it stopped: Inability to recruit due to COVID-19 pandemic restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Sequential
- Model description
- Single dose escalation study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allysta Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INC Research Australia Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Ben Snyder, MD, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855565
- Sponsor's protocol ID
- ALY688-SR-101
- Status last verified
- Aug 2021
- First submitted
- 16 Apr 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of ALY688-SR in Generally Healthy Overweight or Obese Adults
- ClinicalTrials.gov ID
- NCT04855565
- Acronym / sponsor ID
- ALY688-SR-101
- Conditions
- Overweight and Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit due to COVID-19 pandemic restrictions
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Allysta PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- INC Research Australia Pty Ltd
- Study start
- 19 May 2021 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 22 Apr 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.
First in human study of ALY688-SR administered as a subcutaneous injection
Detailed description
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ALY688-SR compared to placebo administered as a subcutaneous injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single dose escalation study
| Arm | Type | Receives |
|---|---|---|
| ALY688-SR | Active comparator | Drug: ALY688-SRsingle dose subcutaneous injection |
| Matching placebo for ALY688-SR | Placebo comparator | Drug: ALY688-SRsingle dose subcutaneous injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index 24 to 35 kg/m2 Body weight 60 to 120 kg,
Key exclusion criteria (1 listed)
- Confirmed diabetes on treatment Inadequately managed hypertension Poorly controlled hypercholesterolemia
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 |
|---|---|---|
| ALY688-SRsingle dose subcutaneous injection | Drug | ALY688-SR, Matching placebo for ALY688-SR |
Primary outcome
Change between pre- and post-intervention safety and tolerability assessments
Time frame: baseline, pre-intervention through study completion at 16 days
Incidence of Treatment-Emergent Adverse Events as assessed by lab evaluations, ECG, vital signs and physical examinations
Results and safety
The study was stopped early (reason given: Inability to recruit due to COVID-19 pandemic restrictions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- 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.
Ben Snyder, MD principal investigator
Nucleus Network
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 ALY688-SR in people with Overweight and Obesity, run by Allysta Pharmaceutical 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Aug 2021. 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 was stopped early (reason given: Inability to recruit due to COVID-19 pandemic restrictions). Results are not available in the source record.
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?
Change between pre- and post-intervention safety and tolerability assessments (time frame: baseline, pre-intervention through study completion at 16 days). 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 30 Aug 2021.