NCT07282743ClinicalTrials.gov

Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of GL0034 Among Type II Diabetes Mellitus Subjects Who Are Obese or Overweight With Weight-related Comorbidities

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En resumen

Fase 2285 participantes buscados21 centros2 países

Categorías

Endocrino y metabólico100%

Registrado en 1 registro

ClinicalTrials.govNCT07282743Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses

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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 2025-12-15; recorded start 2026-01-20
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 67 other studies in this databaseCounted from the lead sponsor named in the record (Sun Pharmaceutical Industries Limited)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
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 2 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: 21 sites
Data monitoring committee0/7
Data monitoring committee not stated in the record
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 285 participants (target), run at 21 sites, across 2 countries.

How this score is built

Enrolment24/40
285 participants (target)
Site count16/25
21 sites
Country count7/15
2 countries
Planned duration6/10
Planned over about 19 months
Sponsor scale7/10
Sun Pharmaceutical Industries Limited has led 65 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.

Resumen

This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus subjects who are obese or overweight with weight-related comorbidities. Subjects will be put on either one of the four treatment arms (GL0034, once a week, subcutaneous injection) or placebo arm (once a week, subcutaneous injection) following initial dose-up titration that takes up to approximately 20 weeks. The primary end point is change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants.

Afecciones

Type II Diabetes Mellitus

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

Inclusion Criteria: 1. Participant is willing and able to sign a written ICF or e-ICF. 2. Men or women ≥18 years of age at the time of signing ICF or e-ICF. 3. Participant was diagnosed with type II diabetes mellitus at least 180 days prior to the day of screening. 4. Participant has a HbA1c level of 7.0 - 10.5%, both inclusive, at the time of screening. 5. Participant has a stable BMI ≥27 kg/m2 for at least 90 days prior to screening. 6. Participant is able and willing to undergo fasting blood draw (i.e. at least 8 hours after last eating or drinking) as well as 7-point SMBG check for 3 consecutive days prior to designated scheduled visits by using a home glucometer that is provided by the study site. 7. Participant on stable daily doses of metformin for at least 90 days prior to screening. 8. Participant who are on metformin and not the following agents for at least 3 months prior to screening: DPP-4 inhibitors, alpha-glucosidase enzyme inhibitors, sulfonylureas, sodium-glucose transport 2 inhibitors, amylin analogues, thiazolidinediones, any insulin product, herbals, or ayurvedic agents. Participants are encouraged to follow the standard of care in their study regions, including appropriate diet and lifestyle modifications, rather than make abrupt change in the diabetic management prior to screening without consulting their physicians. 9. If participant is a woman of childbearing potential (WOCP)\*, she must agree to use a highly effective method of contraception during the study in conjunction with a barrier method of contraception, and continue the same contraception method at least one months after the last dose of study drug. Highly effective methods of contraception include one of the following: intrauterine device, injectable hormonal contraceptive, contraceptive patch or implant, partner's vasectomy, bilateral tubal occlusion, and sexual abstinence. \*WOCP includes women who are not surgically sterilized \[using hysterectomy/bilateral salpingectomy/bilateral oophorectomy\] or post-menopausal \[defined as 12 consecutive months of amenorrhea without an alternative medical cause\]. 10. Male participants with female partners of child-bearing potential must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy) during the study. In addition, male participants agree to use the same method of contraception for an additional 30 days after the last IP dose and refrain from donating sperm during this period. In the event that the female partner of the male participant becomes pregnant during the study period + 30 days after the last IP dose, an ICF will be provided to the female partner in order to monitor the female partner, pregnancy, and the newborn. 11. If participant is a WOCP, she must have a negative serum pregnancy test (SPT) at Screening and a negative urine pregnancy at baseline, with results available before IP administration. 12. Participant is willing and able to comply with the study protocol, visit schedule, and other study-related instructions and procedures. 13. Participant is willing and able to independently record the response on various scales and make entries using the e-Patient reported outcomes (ePRO) device. Exclusion Criteria: 1. Participants who have a history of type I diabetes mellitus. 2. A self-reported change in \>5% of body weight within 90 days before screening irrespective of medical records. 3. History of pancreatitis (acute or chronic) or \>3 hypoglycemic episodes (blood glucose level \<70 mg/dL or 3.9 mmol/L) within 90 days prior to screening. 4. Diagnosis of chronic kidney disease with estimated glomerular filtration rate \<60. 5. Poorly controlled hypertension with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg. 6. Poorly controlled hypothyroidism defined as thyroid-stimulating hormone \>6 mIU/L or \<0.4 mIU/L. 7. Diabetes mellitus and/or obesity that is induced by endocrine disorders (e.g. Cushing Syndrome) or medication use (e.g. corticosteroids) as judged by the Investigator. 8. Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed \>1 year before screening is allowed). Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, previous interventions that, due to reversal or removal, does not have any influence on the participant's weight, in the opinion of the Investigator, are allowed. 9. History of major depressive disorder within 2 years before randomization. 10. History of other severe psychiatric illnesses (i.e. schizophrenia, bipolar disorder). 11. Any lifetime history of a suicidal attempt. 12. Participants with any medical condition \[i.e. gastroparesis, uncontrolled gastroesophageal reflux disease, or diarrhea with or without a diagnosis of a diagnosis of irritable bowel syndrome\] that, in the opinion of the Investigator, can confound study efficacy assessments or safety concerns. 13. Participant had a myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to IP administration. 14. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, sudden cardiac death, unexplained death, long QT syndrome, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member. 15. Surgery scheduled for the trial duration period, except for very minor surgical procedures in the opinion of the Investigator. 16. Participants with active malignancy. Note: participants with past history of malignancy may be included if: * Participant has history of basal cell or in-situ squamous cell carcinoma of skin that has been adequately treated and resolved, per Investigator's judgement. * Participant has history of other malignancy that have been adequately treated with no evidence of recurrence/relapse within the last 5 years, per Investigator's judgement. 17. Presence of diabetic retinopathy \[both nonproliferative diabetic retinopathy and proliferative diabetic retinopathy\]) or maculopathy in either eye that was verified by a fundoscopic examination within 90 days prior to screening or during the study. 18. Known moderate to severe coronary, carotid, or peripheral vascular disease that has planned or will likely need revascularization during the study. 19. Participants with any other condition, which in the opinion of the Investigator, precludes participation in the study (either poses an unacceptable risk to the participant or interferes with assessment/interpretation of study outcomes). 20. Known hypersensitivity to the study IP or its excipients. 21. History of alcohol or drug abuse in the previous two years (Alcohol abuse in this study is defined as \>14 standard drinks per week in men or \>7 standard drinks per week in women ± a history of alcohol withdrawal symptoms ± institutionalized/hospitalized due to alcohol use ± binge drinking with \>5 standard drinks on a single occasion in men or \>4 standard drinks on a single occasion in women). 22. Participants are taking, or will start, medications with narrow therapeutic index such as digoxin, warfarin, etc, or those that will prolong QTc interval. 23. Participants received any medications for the treatment of type II diabetes mellitus other than those stated in the inclusion criteria within 90 days before screening. Short-term insulin treatment for a maximum of 7 days prior to screening is allowed. Prior insulin treatment for gestational diabetes is also allowed. 24. Participants who have used medications in the family of GLP-1 agonists in the past. 25. Treatment with any herbal diet supplements, over-the-counter diet medications as an attempt to lose weight within 90 days before screening. 26. Treatment with orlistat, lorcaserin, zonisamide, topiramate, phentermine, buproprion, or naltrexone that could promote weight loss within 90 days before screening. 27. Participation in any organized or online weight-reduction program (i.e. Weight Watchers) within 90 days before screening. 28. Screening calcitonin ≥50 ng/L (pg/mL). 29. Participants having clinically significant abnormal values on Screening laboratory tests or other evidence of uncontrolled disease involving any system-organ (e.g., cardiovascular, pulmonary, renal, hepatic, neurological, endocrine, gastrointestinal, psychiatric etc.) that, in the opinion of the Investigator, would put the participant at risk by participating in the study. 30. Participants with positive urine drug screen \[amphetamine, barbiturate, benzodiazepine, cocaine, opiates\] with substances that are not part of participant's routine medical care. Tetrahydrocannabinols is acceptable for as long as its use is legally allowed by participant 's home state or country. 31. Participants have clinically significant ECG abnormality , including QTcF \>450 msec for males and \>470 msec for females, or at high risk for arrhythmia such as judged by the Investigator conditions listed in Criteria #13 above, brady-arrhythmias, tachy-arrhythmias, ventricular arrhythmias, torsade de pointes, high-degree atrioventricular block, or New York Heart Association Class III and IV congestive heart failure. 32. Pregnant or lactating females.

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

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 2
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	TRIPLE (3)
Inscripción	285 participantes buscados

Patrocinador y colaboradores

Sun Pharmaceutical Industries Limited Patrocinador

Grupos e intervenciones

Arm 1EXPERIMENTAL
Dose Up-titration Period: Participants receive GL0034 starting at Dose Level 1 with titration up to Dose Level 2 for approximately 20 weeks Maintenance Treatment Period: Once participants reach their final designated doses, they will continue to receive the final designated doses by weekly subcutaneous administration until the end of Week 48.
Arm 2EXPERIMENTAL
Dose Up-titration Period: Participants receive GL0034 starting at Dose Levels 1 to 3 with titration up to Dose Level 2 for approximately 20 weeks Maintenance Treatment Period: Once participants reach their final designated doses, they will continue to receive the final designated doses by weekly subcutaneous administration until the end of Week 48.
Arm 3EXPERIMENTAL
Dose Up-titration Period: Participants receive GL0034 starting at Dose Levels 1 to 4 with titration up to Dose Level 2 for approximately 20 weeks Maintenance Treatment Period: Once participants reach their final designated doses, they will continue to receive the final designated doses by weekly subcutaneous administration until the end of Week 48.
Arm 4EXPERIMENTAL
Dose Up-titration Period: Participants receive GL0034 starting at Dose Levels 1 to 6 with titration up to Dose Level 2 for approximately 20 weeks Maintenance Treatment Period: Once participants reach their final designated doses, they will continue to receive the final designated doses by weekly subcutaneous administration until the end of Week 48.
PlaceboPLACEBO_COMPARATOR
Dose Up-titration Period: Participants receive sham placebo up titration, once weekly for approximately 20 weeks. Maintenance Treatment Period: Participants will continue to receive placebo once weekly through subcutaneous administration until the end of Week 48.

Intervenciones

Fármaco GL0034 Dose Level 1
Dose 1, once a week
Fármaco GL0034 Dose Level 2
Dose 2, once a week
Fármaco GL0034 Dose Level 3
Dose 3, once a week
Fármaco GL0034 Dose Level 4
Dose 4, once a week
Fármaco GL0034 Dose Level 5
Dose 5, once a week
Fármaco GL0034 Dose Level 6
Dose 6, once a week
Otro Placebo
Placebo, once a week

Variables de resultado

Variable de resultado principal
Change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants
Plazo Week 36
Variable de resultado secundaria
Number of participants with an HbA1c <7.0%, <6.5%, or <5.7%
Plazo Week 36 or Week 48
Variable de resultado secundaria
Change in HbA1c levels from baseline (Week 0) to Week 48 following treatments in all participants
Plazo Week 48
Variable de resultado secundaria
Change in HbA1c levels over time from baseline (Week 0) to Week 48 following treatments in all participants
Plazo Week 48
Variable de resultado secundaria
Percent change (%) in body weight and BMI from baseline (Week 0) to Week 36, Week 48, and over time from baseline to Week 48 following treatments in all participants.
Plazo Week 36 and Week 48
Variable de resultado secundaria
Percent of participants who achieved ≥5%, ≥10%, ≥15%, >20%, >25% weight loss from baseline to Week 36 or Week 48 of treatments in all participants.
Plazo Week 36 or Week 48

Fechas

Fechas
Fecha de inicio	20 de enero de 2026 (real)
Finalización principal	1 de abril de 2027 (estimada)
Finalización	1 de agosto de 2027 (estimada)
Primera publicación	15 de diciembre de 2025 (real)
Última actualización	18 de marzo de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	marzo de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

21 centros están en reclutamiento

India

India
Centro	Ciudad	Estado o región	Estado
Life Care Hospital and Research Centre	Bangalore	Karnataka	En reclutamiento
Madras Diabetes Research Foundation (MDRF)	Chennai	Tamil Nadu	En reclutamiento
Endolife Specialty Hospitals Pvt. Ltd.	Guntur	Andhra Pradesh	En reclutamiento
Nirmal Hospital Private Limited	Kolhāpur	Maharashtra	En reclutamiento
Government Medical College	Kozhikode	Kerala	En reclutamiento
BSES Municipal General Hospital	Mumbai	Maharashtra	En reclutamiento
Seth G. S. medical college and KEM hospital	Mumbai	Maharashtra	En reclutamiento
Topiwala National Medical College & BYL Nair Hospital	Mumbai	Maharashtra	En reclutamiento
All India Institute of Medical Sciences	New Delhi	National Capital Territory of Delhi	En reclutamiento
Lady Hardinge Medical College and S.S.K. Hospital	New Delhi	National Capital Territory of Delhi	En reclutamiento
LMMF's Deenanath Mangeshkar Hospital and Research Center	Pune	Maharashtra	En reclutamiento
Jothydevs Diabetes Research Centre	Trivandrum	Kerala	En reclutamiento

United States

United States
Centro	Ciudad	Estado o región	Estado
AMR Clinical, El Dorado	El Dorado	Kansas	En reclutamiento
Family First Medical Research Center	Hialeah Gardens	Florida	En reclutamiento
Alliance for Multispecialty Research (AMR Clinical) - Wichita East	Lakeland	Florida	En reclutamiento
CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)	Lakeland	Florida	En reclutamiento
Lynn Institute of the Ozarks	Little Rock	Arkansas	En reclutamiento
GTL Medical & Research Group	Miami	Florida	En reclutamiento
AMR Clinical - Newton	Newton	Kansas	En reclutamiento
Lynn Health Science Institute - Oklahoma City	Oklahoma City	Oklahoma	En reclutamiento
Florida Institute for Clinical Research LLC	Orlando	Florida	En reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07282743