NCT06703021

Brief Summary

Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2026

Completed
Last Updated

April 28, 2026

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

November 15, 2024

Last Update Submit

April 24, 2026

Conditions

ObesityOverweightChronic Weight Management

Keywords

ACCESS IIObesityOverweightGSBR-1290Chronic weight managementObeseSmall molecule GLP-1 receptor agonistStructure Therapeutics

Outcome Measures

Primary Outcomes (5)

  • Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Baseline and week 44

  • Adverse events of special interest

    Baseline and week 44

  • Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis

    Baseline and week 44

  • Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to : heart rate and QRS duration

    Baseline and week 44

  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature

    Baseline and week 44

Secondary Outcomes (5)

  • Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau)

    Baseline and week 44

  • Maximum Observed Plasma Concentration (Cmax) of aleniglipron

    Baseline and week 44

  • Trough Concentrations (Ctrough) of aleniglipron

    Baseline and week 44

  • Time of Maximum Observed Plasma Concentration (Tmax) of aleniglipron

    Baseline and week 44

  • Terminal Elimination Half-life (t1/2) for aleniglipron

    Baseline and week 44

Other Outcomes (9)

  • Percent change in body weight

    Baseline and week 44

  • Change in body weight (absolute)

    Baseline and week 44

  • Percentage of participants who achieve ≥5% reduction in body weight at Week 44

    Baseline and week 44

  • +6 more other outcomes

Study Arms (4)

Sentinel

EXPERIMENTAL

Participants will receive aleniglipron or placebo administered orally.

Drug: aleniglipron or placebo

Cohort 1a

EXPERIMENTAL

Participants will receive aleniglipron or placebo administered orally.

Drug: aleniglipron or placebo

Cohort 1b

EXPERIMENTAL

Participants will receive aleniglipron or placebo administered orally.

Drug: aleniglipron or placebo

Cohort 1c

EXPERIMENTAL

Participants will receive aleniglipron or placebo administered orally.

Drug: aleniglipron or placebo

Interventions

aleniglipron or placeboDRUG

Drug: aleniglipron administered orally; Drug: placebo administered orally

Cohort 1a

Eligibility Criteria

Age18 Years - 79 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity

You may not qualify if:

  • Previous documented diagnosis of diabetes mellitus
  • Self-reported change in body weight \>5% within 3 months before Screening
  • Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening)
  • Use of medications intended to promote weight loss, within 6 months prior to Screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

ACCESS II Research Site

Glendale, California, 91206, United States

Location

ACCESS II Research Site

Montclair, California, 91763, United States

Location

ACCESS II Research Site

Valparaiso, Indiana, 46383, United States

Location

ACCESS II Research Site

West Des Moines, Iowa, 50265, United States

Location

ACCESS II Research Site

Medford, Oregon, 97504, United States

Location

ACCESS II Research Site

East Greenwich, Rhode Island, 02818, United States

Location

ACCESS II Research Site

North Charleston, South Carolina, 29405, United States

Location

ACCESS II Research Site

Dallas, Texas, 75042, United States

Location

ACCESS II Research Site

San Antonio, Texas, 78240, United States

Location

ACCESS II Research Site

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 25, 2024

Study Start

December 20, 2024

Primary Completion

January 12, 2026

Study Completion

January 12, 2026

Last Updated

April 28, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request

Shared Documents
STUDY PROTOCOL
Time Frame
Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product has been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria
Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Structure Therapeutics does not grant external requests for individual de-identified patient data for the following purposes: * Re-evaluating safety and efficacy end points already addressed in the product labelling, * Assessing safety or efficacy for an indication in current development Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.

Locations

US(10)