ObesityPhase 1NCT07624071
A Study to Evaluate ALN-6222 in Participants With Obesity
A Phase 1 study testing ALN-6222 in people with Obesity, run by Alnylam Pharmaceuticals at 1 site in Canada.
Trial summary
This is a first in human, randomized, double-blind (DB), placebo-controlled, single ascending dose (SAD), Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ALN-6222 administered subcutaneously (SC) in adult participants with obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- ALN-6222
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2026to 14 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Is an adult patient with a body mass index ≥30 kg/m^2 to <40 kg/m^2
- Has a hemoglobin A1c <6.5%
Who cannot join
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN)
- Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
- Has an estimated glomerular filtration (eGFR) of <60 mL/min/1.73m^2 at screening
- Note: other protocol defined inclusion / exclusion criteria apply
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ALN-6222 in Adult Participants With Obesity
This is a first in human, randomized, double-blind (DB), placebo-controlled, single ascending dose (SAD), Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ALN-6222 administered subcutaneously (SC) in adult participants with obesity.
- Conditions
- Obesity
- Being tested
- ALN-6222, Placebo
- Keywords
- siRNA, RNAi therapeutic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-6222Drug
ALN-6222 will be administered subcutaneously (SC).
PlaceboDrug
Placebo will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| ALN-6222 | Experimental | Participants will be administered a single dose of ALN-6222. Receives: Drug: ALN-6222 |
| Placebo | Placebo comparator | Participants will be administered a single dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Measured: Up to 12 months
Secondary outcomes (2)
Concentrations of ALN-6222 in Plasma
Measured: Predose and up to 3 days postdose
Change from Baseline Protein Markers in Plasma
Measured: Predose and up to 12 months postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start4 Jun 2026
- Primary completion14 Dec 2027 (estimated)
- Study completion14 Dec 2027 (estimated)
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.
- More trials run by Alnylam PharmaceuticalsThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Alnylam Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624071
- Sponsor's protocol ID
- ALN-6222-001
- Status last verified
- Oct 2026
- First submitted
- 29 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ALN-6222 in Adult Participants With Obesity
- ClinicalTrials.gov ID
- NCT07624071
- Acronym / sponsor ID
- ALN-6222-001
- Conditions
- Obesity
- Keywords
- siRNA, RNAi therapeutic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Alnylam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 14 Dec 2027 (estimated)
- Study completion
- 14 Dec 2027 (estimated)
- First posted
- 3 Jun 2026 (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 first in human, randomized, double-blind (DB), placebo-controlled, single ascending dose (SAD), Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ALN-6222 administered subcutaneously (SC) in adult participants with obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALN-6222 | Experimental | Drug: ALN-6222Participants will be administered a single dose of ALN-6222. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered a single dose of placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is an adult patient with a body mass index ≥30 kg/m^2 to <40 kg/m^2
- Has a hemoglobin A1c <6.5%
Key exclusion criteria (4 listed)
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN)
- Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
- Has an estimated glomerular filtration (eGFR) of <60 mL/min/1.73m^2 at screening
- Note: other protocol defined inclusion / exclusion criteria apply
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 |
|---|---|---|
| ALN-6222ALN-6222 will be administered subcutaneously (SC). | Drug | ALN-6222 |
| PlaceboPlacebo will be administered SC. | Drug | Placebo |
Primary outcome
Frequency of Adverse Events
Time frame: Up to 12 months
2 secondary outcomes
Concentrations of ALN-6222 in Plasma
Time frame: Predose and up to 3 days postdose
Change from Baseline Protein Markers in Plasma
Time frame: Predose and up to 12 months postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- 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.
Medical Director study director
Alnylam Pharmaceuticals
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 ALN-6222 in people with Obesity, run by Alnylam Pharmaceuticals at 1 site in Canada.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alnylam Clinical Trial Information Line (1-877-ALNYLAM, clinicaltrials@alnylam.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (time frame: Up to 12 months). 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 21 Oct 2026.