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)
Kurz gefasst
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 Teilnehmende gesucht74 Studienzentren1 Land
Kategorien
In 1 Register registriert
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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.
Zusammenfassung
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.
Erkrankungen
- Obesity
- Overweight
- Chronic Weight Management
- Type2 Diabetes Mellitus
Eignung
| Geschlecht | Alle |
|---|---|
| Alter | 18 Years – 79 Years |
| Gesunde Freiwillige | Ja |
Eignung im Wortlaut des Registers
Eignung in einfachen Aussagen
Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.
Studiendesign
| Studientyp | Interventionell |
|---|---|
| Phase | Phase 3 |
| Zuteilung | Randomisiert |
| Interventionsmodell | PARALLEL |
| Primäres Ziel | TREATMENT |
| Verblindung | TRIPLE (3) |
| Teilnahme | 1.100 Teilnehmende gesucht |
Sponsor und Mitwirkende
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics Sponsor
Studienarme und Interventionen
- 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.
Interventionen
- Arzneimittel Placebo
Drug: placebo administered orally
- Arzneimittel aleniglipron
Drug: aleniglipron administered orally
- Arzneimittel aleniglipron
Drug: aleniglipron administered orally
- Arzneimittel aleniglipron
Drug: aleniglipron administered orally
Endpunkte
Primärer Endpunkt
Percent change in body weight from Baseline
Zeitrahmen Baseline and week 76
Sekundärer Endpunkt
Percentage of participants achieving HbA1c target value of ≤6.5%
Zeitrahmen Baseline and week 76
Sekundärer Endpunkt
Change in body weight (absolute) from Baseline
Zeitrahmen Baseline and week 76
Sekundärer Endpunkt
Percentage of participants who achieve ≥5% reduction in body weight
Zeitrahmen Baseline and week 76
Sekundärer Endpunkt
Percentage of participants who achieve ≥10% reduction in body weight
Zeitrahmen Baseline and week 76
Sekundärer Endpunkt
Percentage of participants who achieve ≥15% reduction in body weight
Zeitrahmen Baseline and week 76
Sekundärer Endpunkt
Change in waist circumference from Baseline
Zeitrahmen Baseline and week 76
Sekundärer Endpunkt
Change in HbA1c from Baseline
Zeitrahmen Baseline and week 76
Sekundärer Endpunkt
Change in resting systolic blood pressure from Baseline
Zeitrahmen Baseline and week 76
Sekundärer Endpunkt
Percent change in fasting triglycerides and non-HDL cholesterol from Baseline
Zeitrahmen Baseline and week 76
Daten
| Startdatum | 17. Juli 2026 (tatsächlich) |
|---|---|
| Primärer Abschluss | 1. September 2028 (geschätzt) |
| Abschluss | 1. November 2028 (geschätzt) |
| Erstveröffentlichung | 17. Juni 2026 (tatsächlich) |
| Zuletzt aktualisiert | 11. September 2026 |
| Ergebnisse veröffentlicht | Im Registereintrag nicht angegeben |
| Status zuletzt bestätigt | Juni 2026 |
Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.
Standorte
43 Studienzentren rekrutieren
United States
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| ACCOMPLISH-2 Research Site | Albany | New York | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Albany | New York | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Atlanta | Georgia | Rekrutiert |
| ACCOMPLISH-2 Research Site | Austin | Texas | Rekrutiert |
| ACCOMPLISH-2 Research Site | Birmingham | Alabama | Rekrutiert |
| ACCOMPLISH-2 Research Site | Brooklyn | New York | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Burke | Virginia | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Chandler | Arizona | Rekrutiert |
| ACCOMPLISH-2 Research Site | Charlotte | North Carolina | Rekrutiert |
| ACCOMPLISH-2 Research Site | Chesterfield | Missouri | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | City of Saint Peters | Missouri | Rekrutiert |
| ACCOMPLISH-2 Research Site | Clearwater | Florida | Rekrutiert |
| ACCOMPLISH-2 Research Site | Columbus | Georgia | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Columbus | Ohio | Rekrutiert |
| ACCOMPLISH-2 Research Site | Des Moines | Iowa | Rekrutiert |
| ACCOMPLISH-2 Research Site | Durham | North Carolina | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Escondido | California | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Farmers Branch | Texas | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Fayetteville | North Carolina | Rekrutiert |
| ACCOMPLISH-2 Research Site | Fort Myers | Florida | Rekrutiert |
| ACCOMPLISH-2 Research Site | Fountain Valley | California | Rekrutiert |
| ACCOMPLISH-2 Research Site | Greer | South Carolina | Rekrutiert |
| ACCOMPLISH-2 Research Site | Gulfport | Mississippi | Rekrutiert |
| ACCOMPLISH-2 Research Site | Hazelwood | Missouri | Rekrutiert |
| ACCOMPLISH-2 Research Site | Houston | Texas | Rekrutiert |
| ACCOMPLISH-2 Research Site | Houston | Texas | Rekrutiert |
| ACCOMPLISH-2 Research Site | Iowa City | Iowa | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Jacksonville | Florida | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | La Jolla | California | Rekrutiert |
| ACCOMPLISH-2 Research Site | Lake Forest | California | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Las Vegas | Nevada | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Lawrenceville | Georgia | Rekrutiert |
| ACCOMPLISH-2 Research Site | Leesburg | Florida | Rekrutiert |
| ACCOMPLISH-2 Research Site | Little Rock | Arkansas | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Manassas | Virginia | Rekrutiert |
| ACCOMPLISH-2 Research Site | Mankato | Minnesota | Rekrutiert |
| ACCOMPLISH-2 Research Site | Meridian | Idaho | Rekrutiert |
| ACCOMPLISH-2 Research Site | Methuen | Massachusetts | Rekrutiert |
| ACCOMPLISH-2 Research Site | Miami | Florida | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Minneapolis | Minnesota | Rekrutiert |
| ACCOMPLISH-2 Research Site | Missoula | Montana | Rekrutiert |
| ACCOMPLISH-2 Research Site | Moore | Oklahoma | Rekrutiert |
| ACCOMPLISH-2 Research Site | Morehead City | North Carolina | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Nashville | Tennessee | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Ocala | Florida | Rekrutiert |
| ACCOMPLISH-2 Research Site | Ocoee | Florida | Rekrutiert |
| ACCOMPLISH-2 Research Site | Omaha | Nebraska | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Pembroke Pines | Florida | Rekrutierung noch nicht begonnen |
| ACCOMPLISH-2 Research Site | Philadelphia | Pennsylvania | Rekrutiert |
| ACCOMPLISH-2 Research Site | Phoenix | Arizona | Rekrutierung noch nicht begonnen |
24 weitere Studienzentren sind im Registereintrag aufgeführt.
Studiendokumente
In diesem Registereintrag sind keine Dokumente verlinkt.
Änderungen im Zeitverlauf
- 10. August 2026
Status geändert
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
- 10. August 2026
Rekrutierung eröffnet
Recruitment opened
NOT_YET_RECRUITINGRECRUITING