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)
En resumen
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…
Fase 31100 participantes buscados74 centros1 país
Categorías
Registrado en 1 registro
- ClinicalTrials.govNCT07654374Abrir este registro en ClinicalTrials.govSincronizado la semana pasada
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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.
- Present: Registered before enrolment beganFirst posted 2026-06-17; recorded start 2026-07-17
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Present: Uses blinding (masking)A masking level is recorded in the record
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: 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.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: 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)
- Not stated: 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.
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.
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
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
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.
Resumen
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.
Afecciones
- Obesity
- Overweight
- Chronic Weight Management
- Type2 Diabetes Mellitus
Elegibilidad
| Sexo | Todos |
|---|---|
| Edades | 18 Years – 79 Years |
| Voluntarios sanos | Sí |
Elegibilidad tal como figura en el registro
Elegibilidad en frases sencillas
Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.
Diseño del estudio
| Tipo de estudio | De intervención |
|---|---|
| Fase | Fase 3 |
| Asignación | Aleatorizado |
| Modelo de intervención | PARALLEL |
| Propósito principal | TREATMENT |
| Enmascaramiento | TRIPLE (3) |
| Inscripción | 1100 participantes buscados |
Patrocinador y colaboradores
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics Patrocinador
Grupos e intervenciones
- 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.
Intervenciones
- Fármaco Placebo
Drug: placebo administered orally
- Fármaco aleniglipron
Drug: aleniglipron administered orally
- Fármaco aleniglipron
Drug: aleniglipron administered orally
- Fármaco aleniglipron
Drug: aleniglipron administered orally
Variables de resultado
Variable de resultado principal
Percent change in body weight from Baseline
Plazo Baseline and week 76
Variable de resultado secundaria
Percentage of participants achieving HbA1c target value of ≤6.5%
Plazo Baseline and week 76
Variable de resultado secundaria
Change in body weight (absolute) from Baseline
Plazo Baseline and week 76
Variable de resultado secundaria
Percentage of participants who achieve ≥5% reduction in body weight
Plazo Baseline and week 76
Variable de resultado secundaria
Percentage of participants who achieve ≥10% reduction in body weight
Plazo Baseline and week 76
Variable de resultado secundaria
Percentage of participants who achieve ≥15% reduction in body weight
Plazo Baseline and week 76
Variable de resultado secundaria
Change in waist circumference from Baseline
Plazo Baseline and week 76
Variable de resultado secundaria
Change in HbA1c from Baseline
Plazo Baseline and week 76
Variable de resultado secundaria
Change in resting systolic blood pressure from Baseline
Plazo Baseline and week 76
Variable de resultado secundaria
Percent change in fasting triglycerides and non-HDL cholesterol from Baseline
Plazo Baseline and week 76
Fechas
| Fecha de inicio | 17 de julio de 2026 (real) |
|---|---|
| Finalización principal | 1 de septiembre de 2028 (estimada) |
| Finalización | 1 de noviembre de 2028 (estimada) |
| Primera publicación | 17 de junio de 2026 (real) |
| Última actualización | 11 de septiembre de 2026 |
| Resultados publicados | No indicado en el registro |
| Estado verificado por última vez | junio de 2026 |
Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.
Ubicaciones
43 centros están en reclutamiento
United States
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| ACCOMPLISH-2 Research Site | Albany | New York | Aún no recluta |
| ACCOMPLISH-2 Research Site | Albany | New York | Aún no recluta |
| ACCOMPLISH-2 Research Site | Atlanta | Georgia | En reclutamiento |
| ACCOMPLISH-2 Research Site | Austin | Texas | En reclutamiento |
| ACCOMPLISH-2 Research Site | Birmingham | Alabama | En reclutamiento |
| ACCOMPLISH-2 Research Site | Brooklyn | New York | Aún no recluta |
| ACCOMPLISH-2 Research Site | Burke | Virginia | Aún no recluta |
| ACCOMPLISH-2 Research Site | Chandler | Arizona | En reclutamiento |
| ACCOMPLISH-2 Research Site | Charlotte | North Carolina | En reclutamiento |
| ACCOMPLISH-2 Research Site | Chesterfield | Missouri | Aún no recluta |
| ACCOMPLISH-2 Research Site | City of Saint Peters | Missouri | En reclutamiento |
| ACCOMPLISH-2 Research Site | Clearwater | Florida | En reclutamiento |
| ACCOMPLISH-2 Research Site | Columbus | Georgia | Aún no recluta |
| ACCOMPLISH-2 Research Site | Columbus | Ohio | En reclutamiento |
| ACCOMPLISH-2 Research Site | Des Moines | Iowa | En reclutamiento |
| ACCOMPLISH-2 Research Site | Durham | North Carolina | Aún no recluta |
| ACCOMPLISH-2 Research Site | Escondido | California | Aún no recluta |
| ACCOMPLISH-2 Research Site | Farmers Branch | Texas | Aún no recluta |
| ACCOMPLISH-2 Research Site | Fayetteville | North Carolina | En reclutamiento |
| ACCOMPLISH-2 Research Site | Fort Myers | Florida | En reclutamiento |
| ACCOMPLISH-2 Research Site | Fountain Valley | California | En reclutamiento |
| ACCOMPLISH-2 Research Site | Greer | South Carolina | En reclutamiento |
| ACCOMPLISH-2 Research Site | Gulfport | Mississippi | En reclutamiento |
| ACCOMPLISH-2 Research Site | Hazelwood | Missouri | En reclutamiento |
| ACCOMPLISH-2 Research Site | Houston | Texas | En reclutamiento |
| ACCOMPLISH-2 Research Site | Houston | Texas | En reclutamiento |
| ACCOMPLISH-2 Research Site | Iowa City | Iowa | Aún no recluta |
| ACCOMPLISH-2 Research Site | Jacksonville | Florida | Aún no recluta |
| ACCOMPLISH-2 Research Site | La Jolla | California | En reclutamiento |
| ACCOMPLISH-2 Research Site | Lake Forest | California | Aún no recluta |
| ACCOMPLISH-2 Research Site | Las Vegas | Nevada | Aún no recluta |
| ACCOMPLISH-2 Research Site | Lawrenceville | Georgia | En reclutamiento |
| ACCOMPLISH-2 Research Site | Leesburg | Florida | En reclutamiento |
| ACCOMPLISH-2 Research Site | Little Rock | Arkansas | Aún no recluta |
| ACCOMPLISH-2 Research Site | Manassas | Virginia | En reclutamiento |
| ACCOMPLISH-2 Research Site | Mankato | Minnesota | En reclutamiento |
| ACCOMPLISH-2 Research Site | Meridian | Idaho | En reclutamiento |
| ACCOMPLISH-2 Research Site | Methuen | Massachusetts | En reclutamiento |
| ACCOMPLISH-2 Research Site | Miami | Florida | Aún no recluta |
| ACCOMPLISH-2 Research Site | Minneapolis | Minnesota | En reclutamiento |
| ACCOMPLISH-2 Research Site | Missoula | Montana | En reclutamiento |
| ACCOMPLISH-2 Research Site | Moore | Oklahoma | En reclutamiento |
| ACCOMPLISH-2 Research Site | Morehead City | North Carolina | Aún no recluta |
| ACCOMPLISH-2 Research Site | Nashville | Tennessee | Aún no recluta |
| ACCOMPLISH-2 Research Site | Ocala | Florida | En reclutamiento |
| ACCOMPLISH-2 Research Site | Ocoee | Florida | En reclutamiento |
| ACCOMPLISH-2 Research Site | Omaha | Nebraska | Aún no recluta |
| ACCOMPLISH-2 Research Site | Pembroke Pines | Florida | Aún no recluta |
| ACCOMPLISH-2 Research Site | Philadelphia | Pennsylvania | En reclutamiento |
| ACCOMPLISH-2 Research Site | Phoenix | Arizona | Aún no recluta |
En el registro figuran 24 centros más.
Documentos del estudio
No hay documentos enlazados en este registro.
Cambios a lo largo del tiempo
- 10 de agosto de 2026
Estado modificado
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
- 10 de agosto de 2026
Reclutamiento abierto
Recruitment opened
NOT_YET_RECRUITINGRECRUITING