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)
בקצרה
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…
שלב 3דרושים 1,100 משתתפים74 אתריםמדינה אחת
קטגוריות
רשום במרשם אחד
- ClinicalTrials.govNCT07654374פתיחת רשומה זו ב־ClinicalTrials.govסונכרן השבוע שעבר
מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.
מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.
מתעניינים במחקר הזה?
התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.
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.
תקציר
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.
מצבים רפואיים
- Obesity
- Overweight
- Chronic Weight Management
- Type2 Diabetes Mellitus
זכאות
| מין | הכול |
|---|---|
| גילאים | 18 Years – 79 Years |
| מתנדבים בריאים | כן |
זכאות כפי שנכתבה במרשם
זכאות במשפטים פשוטים
הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.
תכנון המחקר
| סוג המחקר | התערבותי |
|---|---|
| שלב | שלב 3 |
| הקצאה | אקראי |
| מודל ההתערבות | PARALLEL |
| מטרה ראשית | TREATMENT |
| הסתרה | TRIPLE (3) |
| גיוס | דרושים 1,100 משתתפים |
נותן חסות ושותפים
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics נותן חסות
זרועות והתערבויות
- 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.
התערבויות
- תרופה Placebo
Drug: placebo administered orally
- תרופה aleniglipron
Drug: aleniglipron administered orally
- תרופה aleniglipron
Drug: aleniglipron administered orally
- תרופה aleniglipron
Drug: aleniglipron administered orally
מדדי תוצאה
מדד תוצאה ראשוני
Percent change in body weight from Baseline
מסגרת זמן Baseline and week 76
מדד תוצאה משני
Percentage of participants achieving HbA1c target value of ≤6.5%
מסגרת זמן Baseline and week 76
מדד תוצאה משני
Change in body weight (absolute) from Baseline
מסגרת זמן Baseline and week 76
מדד תוצאה משני
Percentage of participants who achieve ≥5% reduction in body weight
מסגרת זמן Baseline and week 76
מדד תוצאה משני
Percentage of participants who achieve ≥10% reduction in body weight
מסגרת זמן Baseline and week 76
מדד תוצאה משני
Percentage of participants who achieve ≥15% reduction in body weight
מסגרת זמן Baseline and week 76
מדד תוצאה משני
Change in waist circumference from Baseline
מסגרת זמן Baseline and week 76
מדד תוצאה משני
Change in HbA1c from Baseline
מסגרת זמן Baseline and week 76
מדד תוצאה משני
Change in resting systolic blood pressure from Baseline
מסגרת זמן Baseline and week 76
מדד תוצאה משני
Percent change in fasting triglycerides and non-HDL cholesterol from Baseline
מסגרת זמן Baseline and week 76
תאריכים
| תאריך התחלה | 17 ביולי 2026 (בפועל) |
|---|---|
| סיום ראשוני | 1 בספטמבר 2028 (משוער) |
| סיום | 1 בנובמבר 2028 (משוער) |
| פורסם לראשונה | 17 ביוני 2026 (בפועל) |
| עודכן לאחרונה | 11 בספטמבר 2026 |
| התוצאות פורסמו | לא צוין ברשומת המרשם |
| המצב אומת לאחרונה | יוני 2026 |
בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.
מיקומים
43 אתרים מגייסים
United States
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| ACCOMPLISH-2 Research Site | Albany | New York | טרם מגייס |
| ACCOMPLISH-2 Research Site | Albany | New York | טרם מגייס |
| ACCOMPLISH-2 Research Site | Atlanta | Georgia | מגייס |
| ACCOMPLISH-2 Research Site | Austin | Texas | מגייס |
| ACCOMPLISH-2 Research Site | Birmingham | Alabama | מגייס |
| ACCOMPLISH-2 Research Site | Brooklyn | New York | טרם מגייס |
| ACCOMPLISH-2 Research Site | Burke | Virginia | טרם מגייס |
| ACCOMPLISH-2 Research Site | Chandler | Arizona | מגייס |
| ACCOMPLISH-2 Research Site | Charlotte | North Carolina | מגייס |
| ACCOMPLISH-2 Research Site | Chesterfield | Missouri | טרם מגייס |
| ACCOMPLISH-2 Research Site | City of Saint Peters | Missouri | מגייס |
| ACCOMPLISH-2 Research Site | Clearwater | Florida | מגייס |
| ACCOMPLISH-2 Research Site | Columbus | Georgia | טרם מגייס |
| ACCOMPLISH-2 Research Site | Columbus | Ohio | מגייס |
| ACCOMPLISH-2 Research Site | Des Moines | Iowa | מגייס |
| ACCOMPLISH-2 Research Site | Durham | North Carolina | טרם מגייס |
| ACCOMPLISH-2 Research Site | Escondido | California | טרם מגייס |
| ACCOMPLISH-2 Research Site | Farmers Branch | Texas | טרם מגייס |
| ACCOMPLISH-2 Research Site | Fayetteville | North Carolina | מגייס |
| ACCOMPLISH-2 Research Site | Fort Myers | Florida | מגייס |
| ACCOMPLISH-2 Research Site | Fountain Valley | California | מגייס |
| ACCOMPLISH-2 Research Site | Greer | South Carolina | מגייס |
| ACCOMPLISH-2 Research Site | Gulfport | Mississippi | מגייס |
| ACCOMPLISH-2 Research Site | Hazelwood | Missouri | מגייס |
| ACCOMPLISH-2 Research Site | Houston | Texas | מגייס |
| ACCOMPLISH-2 Research Site | Houston | Texas | מגייס |
| ACCOMPLISH-2 Research Site | Iowa City | Iowa | טרם מגייס |
| ACCOMPLISH-2 Research Site | Jacksonville | Florida | טרם מגייס |
| ACCOMPLISH-2 Research Site | La Jolla | California | מגייס |
| ACCOMPLISH-2 Research Site | Lake Forest | California | טרם מגייס |
| ACCOMPLISH-2 Research Site | Las Vegas | Nevada | טרם מגייס |
| ACCOMPLISH-2 Research Site | Lawrenceville | Georgia | מגייס |
| ACCOMPLISH-2 Research Site | Leesburg | Florida | מגייס |
| ACCOMPLISH-2 Research Site | Little Rock | Arkansas | טרם מגייס |
| ACCOMPLISH-2 Research Site | Manassas | Virginia | מגייס |
| ACCOMPLISH-2 Research Site | Mankato | Minnesota | מגייס |
| ACCOMPLISH-2 Research Site | Meridian | Idaho | מגייס |
| ACCOMPLISH-2 Research Site | Methuen | Massachusetts | מגייס |
| ACCOMPLISH-2 Research Site | Miami | Florida | טרם מגייס |
| ACCOMPLISH-2 Research Site | Minneapolis | Minnesota | מגייס |
| ACCOMPLISH-2 Research Site | Missoula | Montana | מגייס |
| ACCOMPLISH-2 Research Site | Moore | Oklahoma | מגייס |
| ACCOMPLISH-2 Research Site | Morehead City | North Carolina | טרם מגייס |
| ACCOMPLISH-2 Research Site | Nashville | Tennessee | טרם מגייס |
| ACCOMPLISH-2 Research Site | Ocala | Florida | מגייס |
| ACCOMPLISH-2 Research Site | Ocoee | Florida | מגייס |
| ACCOMPLISH-2 Research Site | Omaha | Nebraska | טרם מגייס |
| ACCOMPLISH-2 Research Site | Pembroke Pines | Florida | טרם מגייס |
| ACCOMPLISH-2 Research Site | Philadelphia | Pennsylvania | מגייס |
| ACCOMPLISH-2 Research Site | Phoenix | Arizona | טרם מגייס |
24 אתרים נוספים מצוינים ברשומת המרשם.
מסמכי המחקר
לא צורפו מסמכים ברשומת מרשם זו.
שינויים לאורך זמן
- 10 באוגוסט 2026
המצב השתנה
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
- 10 באוגוסט 2026
הגיוס נפתח
Recruitment opened
NOT_YET_RECRUITINGRECRUITING