A Study to Evaluate ALN-6222 in Participants With Obesity | NCT07624071

Studies
A Study to Evaluate ALN-6222 in Participants With Obesity

NCT07624071

Sponsor

Alnylam Pharmaceuticals

Status

Recruiting

Last Update Posted

Jun 29, 2026Actual

Enrollment

88Estimated

Phase

Phase 1

Conditions

Obesity

Interventions

ALN-6222
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2026Actual

Primary Completion Date

Dec 14, 2027Estimated

Completion Date

Dec 14, 2027Estimated

First Submitted Date

May 29, 2026

First Submission Date that Met QC Criteria

May 29, 2026

First Posted Date

Jun 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2026

Last Update Posted Date

Jun 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALN-6222	Experimental	Participants will be administered a single dose of ALN-6222.	Drug: ALN-6222
Placebo	Placebo Comparator	Participants will be administered a single dose of placebo.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALN-6222	Drug	ALN-6222 will be administered subcutaneously (SC).	ALN-6222

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of Adverse Events		Up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Concentrations of ALN-6222 in Plasma		Predose and up to 3 days postdose
Change from Baseline Protein Markers in Plasma		Predose and up to 12 months postdose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria -

Is an adult patient with a body mass index ≥30 kg/m^2 to <40 kg/m^2
Has a hemoglobin A1c <6.5%

Exclusion Criteria -

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alnylam Clinical Trial Information Line	Contact	1-877-ALNYLAM		clinicaltrials@alnylam.com
Alnylam Clinical Trial Information Line	Contact	1-877-256-9526		clinicaltrials@alnylam.com

Overall Officials

Name	Affiliation	Role
Medical Director	Alnylam Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trial Site	Recruiting	Mount Royal		H3P 3P1	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided