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NCT07654361ClinicalTrials.gov

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity

RecruitingTaking participants now, according to the registry record.
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In brief

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie…

Phase 33,600 participants sought71 sites1 country

Categories

Endocrine & metabolic83%Cardiovascular17%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2026-06-17; recorded start 2026-07-13
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 5 other studies in this databaseCounted from the lead sponsor named in the record (Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 3 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding16/20

    Triple-blind

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 71 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study: 3,600 participants (target), run at 71 sites.

How this score is built
  • Enrolment35/40

    3,600 participants (target)

  • Site count21/25

    71 sites

  • Country count0/15

    Single country

  • Planned duration7/10

    Planned over about 28 months

  • Sponsor scale2/10

    Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics has led 6 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.

Conditions

  • Obesity
  • Overweight
  • Chronic Weight Management

Eligibility

SexAll
Ages18 Years – 79 Years
Healthy volunteersNo

Eligibility as written in the registry

Inclusion Criteria: * Signed informed consent * BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities. Exclusion Criteria: * Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes. * Self-reported change in body weight \>5 kg within 3 months before Screening. * Have prior or planned surgical or non-surgical treatment for obesity. * Have or plan to have endoscopic and/or device-based therapy for obesity. * Have obesity induced by other endocrine disorders. * Impaired renal function at Screening * Chronic malabsorption

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 3
AllocationRandomised
Intervention modelPARALLEL
Primary purposeTREATMENT
MaskingTRIPLE (3)
Enrolment3,600 participants sought

Sponsor and collaborators

  • Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics Sponsor

Arms and interventions

  • aleniglipron Arm 1EXPERIMENTAL

    Participants will receive aleniglipron administered orally.

  • aleniglipron Arm 2EXPERIMENTAL

    Participants will receive aleniglipron administered orally.

  • aleniglipron Arm 3EXPERIMENTAL

    Participants will receive aleniglipron administered orally.

  • Placebo Arm 4EXPERIMENTAL

    Participants will receive placebo administered orally.

Interventions

  • Drug Aleniglipron

    Drug: aleniglipron administered orally Drug

  • Drug Placebo

    Drug: placebo administered orally

Outcome measures

  1. Primary outcome

    Percent change in body weight from Baseline

    Time frame Baseline and Week 76

  2. Secondary outcome

    Change in body weight (absolute) from Baseline

    Time frame Baseline and week 76

  3. Secondary outcome

    Percentage of participants who achieve ≥5% reduction in body weight

    Time frame Baseline and week 76

  4. Secondary outcome

    Percentage of participants who achieve ≥10% reduction in body weight

    Time frame Baseline and week 76

  5. Secondary outcome

    Percentage of participants who achieve ≥15% reduction in body weight

    Time frame Baseline and week 76

  6. Secondary outcome

    Percentage of participants who achieve ≥20% reduction in body weight

    Time frame Baseline and week 76

  7. Secondary outcome

    Change in waist circumference from Baseline

    Time frame Baseline and week 76

  8. Secondary outcome

    Change in resting systolic blood pressure from Baseline

    Time frame Baseline and week 76

  9. Secondary outcome

    Percent change in fasting triglycerides and non-HDL cholesterol from Baseline

    Time frame Baseline and week 76

  10. Secondary outcome

    Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline

    Time frame Baseline and week 76

  11. Secondary outcome

    Change in HbA1c from Baseline

    Time frame Baseline and week 76

  12. Secondary outcome

    Change in body mass index from Baseline

    Time frame Baseline and week 76

  13. Secondary outcome

    Percent change in fasting total cholesterol from Baseline

    Time frame Baseline and week 76

  14. Secondary outcome

    Change in fasting glucose from Baseline

    Time frame Baseline and week 76

  15. Secondary outcome

    Change in resting diastolic blood pressure from Baseline

    Time frame Baseline and week 76

  16. Other outcome

    Percentage of participants who achieve ≥25% reduction in body weight

    Time frame Baseline and week 76

Dates

Start dateJuly 13, 2026 (actual)
Primary completionSeptember 1, 2028 (estimated)
CompletionNovember 1, 2028 (estimated)
First postedJune 17, 2026 (actual)
Last updatedAugust 10, 2026
Results postedNot stated in the registry record
Status last verifiedJune 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

13 sites are recruiting

United States

FacilityCityState or regionStatus
ACCOMPLISH-1 Research SiteAlbanyNew YorkNot yet recruiting
ACCOMPLISH-1 Research SiteAnn ArborMichiganNot yet recruiting
ACCOMPLISH-1 Research SiteAustinTexasNot yet recruiting
ACCOMPLISH-1 Research SiteAustinTexasRecruiting
ACCOMPLISH-1 Research SiteBaton RougeLouisianaNot yet recruiting
ACCOMPLISH-1 Research SiteBirminghamAlabamaNot yet recruiting
ACCOMPLISH-1 Research SiteBirminghamAlabamaNot yet recruiting
ACCOMPLISH-1 Research SiteBrooklynNew YorkNot yet recruiting
ACCOMPLISH-1 Research SiteBufordGeorgiaNot yet recruiting
ACCOMPLISH-1 Research SiteButteMontanaNot yet recruiting
ACCOMPLISH-1 Research SiteCharlotteNorth CarolinaRecruiting
ACCOMPLISH-1 Research SiteChesterfieldMissouriNot yet recruiting
ACCOMPLISH-1 Research SiteChicagoIllinoisNot yet recruiting
ACCOMPLISH-1 Research SiteClearwaterFloridaRecruiting
ACCOMPLISH-1 Research SiteColumbusOhioRecruiting
ACCOMPLISH-1 Research SiteColumbusOhioNot yet recruiting
ACCOMPLISH-1 Research SiteColumbusGeorgiaNot yet recruiting
ACCOMPLISH-1 Research SiteDenisonTexasNot yet recruiting
ACCOMPLISH-1 Research SiteDurhamNorth CarolinaNot yet recruiting
ACCOMPLISH-1 Research SiteEscondidoCaliforniaNot yet recruiting
ACCOMPLISH-1 Research SiteFayettevilleNorth CarolinaNot yet recruiting
ACCOMPLISH-1 Research SiteGardenaCaliforniaNot yet recruiting
ACCOMPLISH-1 Research SiteGreerSouth CarolinaNot yet recruiting
ACCOMPLISH-1 Research SiteGulfportMississippiNot yet recruiting
ACCOMPLISH-1 Research SiteHazelwoodMissouriRecruiting
ACCOMPLISH-1 Research SiteHonoluluHawaiiRecruiting
ACCOMPLISH-1 Research SiteHoustonTexasNot yet recruiting
ACCOMPLISH-1 Research SiteHoustonTexasNot yet recruiting
ACCOMPLISH-1 Research SiteIowa CityIowaNot yet recruiting
ACCOMPLISH-1 Research SiteKnoxvilleTennesseeNot yet recruiting
ACCOMPLISH-1 Research SiteLa JollaCaliforniaNot yet recruiting
ACCOMPLISH-1 Research SiteLas VegasNevadaNot yet recruiting
ACCOMPLISH-1 Research SiteLawrencevilleGeorgiaNot yet recruiting
ACCOMPLISH-1 Research SiteLeesburgFloridaNot yet recruiting
ACCOMPLISH-1 Research SiteLouisvilleKentuckyNot yet recruiting
ACCOMPLISH-1 Research SiteMankatoMinnesotaRecruiting
ACCOMPLISH-1 Research SiteMeridianIdahoNot yet recruiting
ACCOMPLISH-1 Research SiteMethuenMassachusettsNot yet recruiting
ACCOMPLISH-1 Research SiteMiamiFloridaNot yet recruiting
ACCOMPLISH-1 Research SiteMissoulaMontanaNot yet recruiting
ACCOMPLISH-1 Research SiteModestoCaliforniaNot yet recruiting
ACCOMPLISH-1 Research SiteMooreOklahomaNot yet recruiting
ACCOMPLISH-1 Research SiteNeedhamMassachusettsNot yet recruiting
ACCOMPLISH-1 Research SiteNew BernNorth CarolinaNot yet recruiting
ACCOMPLISH-1 Research SiteOcalaFloridaNot yet recruiting
ACCOMPLISH-1 Research SiteOcoeeFloridaNot yet recruiting
ACCOMPLISH-1 Research SiteOmahaNebraskaNot yet recruiting
ACCOMPLISH-1 Research SitePembrokeFloridaNot yet recruiting
ACCOMPLISH-1 Research SitePhiladelphiaPennsylvaniaNot yet recruiting
ACCOMPLISH-1 Research SitePhoenixArizonaNot yet recruiting

21 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. August 10, 2026

    Status changed

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. August 10, 2026

    Recruitment opened

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07654361