xMedica

NCT07654374ClinicalTrials.gov

A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

A Long-Term Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Multiple Maintenance Doses of Oral Once Daily Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

RecruitingTaking participants now, according to the registry record.
Contact this study

In brief

This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76…

Phase 31,100 participants sought74 sites1 country

Categories

Endocrine & metabolic100%

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.

Interested in this study?

Sign in or create an account to register your interest and follow this study.

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 2026-07-17
  • 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 4 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 rigourDEFINITIVE

A definitive-grade 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 arm13/15

    Placebo / sham control arm

  • 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: 74 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: 1,100 participants (target), run at 74 sites.

How this score is built
  • Enrolment30/40

    1,100 participants (target)

  • Site count21/25

    74 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

This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.

Conditions

  • Obesity
  • Overweight
  • Chronic Weight Management
  • Type2 Diabetes Mellitus

Eligibility

SexAll
Ages18 Years – 79 Years
Healthy volunteersYes

Eligibility as written in the registry

Inclusion Criteria: * Signed Informed Consent * Have a BMI ≥27.0 kg/m2 at Screening * Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Screening Exclusion Criteria: * Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM. * Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Self-reported change in body weight \>5 kg (11 pounds) within 3 months before Screening. * Have prior or planned surgical or non-surgical treatment for obesity.

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)
Enrolment1,100 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 4PLACEBO_COMPARATOR

    Participants will receive placebo administered orally.

Interventions

  • Drug Placebo

    Drug: placebo administered orally

  • Drug aleniglipron

    Drug: aleniglipron administered orally

  • Drug aleniglipron

    Drug: aleniglipron administered orally

  • Drug aleniglipron

    Drug: aleniglipron administered orally

Outcome measures

  1. Primary outcome

    Percent change in body weight from Baseline

    Time frame Baseline and week 76

  2. Secondary outcome

    Percentage of participants achieving HbA1c target value of ≤6.5%

    Time frame Baseline and week 76

  3. Secondary outcome

    Change in body weight (absolute) from Baseline

    Time frame Baseline and week 76

  4. Secondary outcome

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

    Time frame Baseline and week 76

  5. Secondary outcome

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

    Time frame Baseline and week 76

  6. Secondary outcome

    Percentage of participants who achieve ≥15% 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 HbA1c from Baseline

    Time frame Baseline and week 76

  9. Secondary outcome

    Change in resting systolic blood pressure from Baseline

    Time frame Baseline and week 76

  10. Secondary outcome

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

    Time frame Baseline and week 76

Dates

Start dateJuly 17, 2026 (actual)
Primary completionSeptember 1, 2028 (estimated)
CompletionNovember 1, 2028 (estimated)
First postedJune 17, 2026 (actual)
Last updatedSeptember 11, 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

43 sites are recruiting

United States

FacilityCityState or regionStatus
ACCOMPLISH-2 Research SiteAlbanyNew YorkNot yet recruiting
ACCOMPLISH-2 Research SiteAlbanyNew YorkNot yet recruiting
ACCOMPLISH-2 Research SiteAtlantaGeorgiaRecruiting
ACCOMPLISH-2 Research SiteAustinTexasRecruiting
ACCOMPLISH-2 Research SiteBirminghamAlabamaRecruiting
ACCOMPLISH-2 Research SiteBrooklynNew YorkNot yet recruiting
ACCOMPLISH-2 Research SiteBurkeVirginiaNot yet recruiting
ACCOMPLISH-2 Research SiteChandlerArizonaRecruiting
ACCOMPLISH-2 Research SiteCharlotteNorth CarolinaRecruiting
ACCOMPLISH-2 Research SiteChesterfieldMissouriNot yet recruiting
ACCOMPLISH-2 Research SiteCity of Saint PetersMissouriRecruiting
ACCOMPLISH-2 Research SiteClearwaterFloridaRecruiting
ACCOMPLISH-2 Research SiteColumbusGeorgiaNot yet recruiting
ACCOMPLISH-2 Research SiteColumbusOhioRecruiting
ACCOMPLISH-2 Research SiteDes MoinesIowaRecruiting
ACCOMPLISH-2 Research SiteDurhamNorth CarolinaNot yet recruiting
ACCOMPLISH-2 Research SiteEscondidoCaliforniaNot yet recruiting
ACCOMPLISH-2 Research SiteFarmers BranchTexasNot yet recruiting
ACCOMPLISH-2 Research SiteFayettevilleNorth CarolinaRecruiting
ACCOMPLISH-2 Research SiteFort MyersFloridaRecruiting
ACCOMPLISH-2 Research SiteFountain ValleyCaliforniaRecruiting
ACCOMPLISH-2 Research SiteGreerSouth CarolinaRecruiting
ACCOMPLISH-2 Research SiteGulfportMississippiRecruiting
ACCOMPLISH-2 Research SiteHazelwoodMissouriRecruiting
ACCOMPLISH-2 Research SiteHoustonTexasRecruiting
ACCOMPLISH-2 Research SiteHoustonTexasRecruiting
ACCOMPLISH-2 Research SiteIowa CityIowaNot yet recruiting
ACCOMPLISH-2 Research SiteJacksonvilleFloridaNot yet recruiting
ACCOMPLISH-2 Research SiteLa JollaCaliforniaRecruiting
ACCOMPLISH-2 Research SiteLake ForestCaliforniaNot yet recruiting
ACCOMPLISH-2 Research SiteLas VegasNevadaNot yet recruiting
ACCOMPLISH-2 Research SiteLawrencevilleGeorgiaRecruiting
ACCOMPLISH-2 Research SiteLeesburgFloridaRecruiting
ACCOMPLISH-2 Research SiteLittle RockArkansasNot yet recruiting
ACCOMPLISH-2 Research SiteManassasVirginiaRecruiting
ACCOMPLISH-2 Research SiteMankatoMinnesotaRecruiting
ACCOMPLISH-2 Research SiteMeridianIdahoRecruiting
ACCOMPLISH-2 Research SiteMethuenMassachusettsRecruiting
ACCOMPLISH-2 Research SiteMiamiFloridaNot yet recruiting
ACCOMPLISH-2 Research SiteMinneapolisMinnesotaRecruiting
ACCOMPLISH-2 Research SiteMissoulaMontanaRecruiting
ACCOMPLISH-2 Research SiteMooreOklahomaRecruiting
ACCOMPLISH-2 Research SiteMorehead CityNorth CarolinaNot yet recruiting
ACCOMPLISH-2 Research SiteNashvilleTennesseeNot yet recruiting
ACCOMPLISH-2 Research SiteOcalaFloridaRecruiting
ACCOMPLISH-2 Research SiteOcoeeFloridaRecruiting
ACCOMPLISH-2 Research SiteOmahaNebraskaNot yet recruiting
ACCOMPLISH-2 Research SitePembroke PinesFloridaNot yet recruiting
ACCOMPLISH-2 Research SitePhiladelphiaPennsylvaniaRecruiting
ACCOMPLISH-2 Research SitePhoenixArizonaNot yet recruiting

24 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/NCT07654374