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Type II Diabetes MellitusPhase 2NCT07282743

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

A Phase 2 study testing GL0034 Dose Level 1, GL0034 Dose Level 2 and GL0034 Dose Level 3 in people with Type II Diabetes Mellitus, run by Sun Pharmaceutical Industries Limited at 21 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type II Diabetes Mellitus
What is being tested?
GL0034 Dose Level 1, GL0034 Dose Level 2 and GL0034 Dose Level 3
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
285 participants
Where
21 sitesin 2 countries
Study dates
20 Jan 2026to Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant is willing and able to sign a written ICF or e-ICF.
  • Men or women ≥18 years of age at the time of signing ICF or e-ICF.
  • Participant was diagnosed with type II diabetes mellitus at least 180 days prior to the day of screening.
  • Participant has a HbA1c level of 7.0 - 10.5%, both inclusive, at the time of screening.
  • Participant has a stable BMI ≥27 kg/m2 for at least 90 days prior to screening.
  • 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.
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  • Participant on stable daily doses of metformin for at least 90 days prior to screening.
  • 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.
  • 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].
  • 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.
  • 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.
  • Participant is willing and able to comply with the study protocol, visit schedule, and other study-related instructions and procedures.
  • Participant is willing and able to independently record the response on various scales and make entries using the e-Patient reported outcomes (ePRO) device.

Who cannot join

  • Participants who have a history of type I diabetes mellitus.
  • A self-reported change in >5% of body weight within 90 days before screening irrespective of medical records.
  • 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.
  • Diagnosis of chronic kidney disease with estimated glomerular filtration rate <60.
  • Poorly controlled hypertension with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg.
  • Poorly controlled hypothyroidism defined as thyroid-stimulating hormone >6 mIU/L or <0.4 mIU/L.
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  • 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.
  • 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.
  • History of major depressive disorder within 2 years before randomization.
  • History of other severe psychiatric illnesses (i.e. schizophrenia, bipolar disorder).
  • Any lifetime history of a suicidal attempt.
  • 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.
  • Participant had a myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to IP administration.
  • 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.
  • Surgery scheduled for the trial duration period, except for very minor surgical procedures in the opinion of the Investigator.
  • 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.
  • 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.
  • Known moderate to severe coronary, carotid, or peripheral vascular disease that has planned or will likely need revascularization during the study.
  • 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).
  • Known hypersensitivity to the study IP or its excipients.
  • 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).
  • Participants are taking, or will start, medications with narrow therapeutic index such as digoxin, warfarin, etc, or those that will prolong QTc interval.
  • 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.
  • Participants who have used medications in the family of GLP-1 agonists in the past.
  • Treatment with any herbal diet supplements, over-the-counter diet medications as an attempt to lose weight within 90 days before screening.
  • Treatment with orlistat, lorcaserin, zonisamide, topiramate, phentermine, buproprion, or naltrexone that could promote weight loss within 90 days before screening.
  • Participation in any organized or online weight-reduction program (i.e. Weight Watchers) within 90 days before screening.
  • Screening calcitonin ≥50 ng/L (pg/mL).
  • 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.
  • 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.
  • 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.
  • Pregnant or lactating females.

Trial locations and contacts

21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Head, Regulatory Affairs contact

9122 66455645

Clinical.Trial@sunpharma.com

21 sites in 2 countries

India12 sites, 12 recruiting

  • Life Care Hospital and Research Centre

    Bangalore, Karnataka, 560092

    Recruiting

  • Madras Diabetes Research Foundation (MDRF)

    Chennai, Tamil Nadu, 600086

    Recruiting

  • Endolife Specialty Hospitals Pvt. Ltd.

    Guntur, Andhra Pradesh, 522001

    Recruiting

  • Nirmal Hospital Private Limited

    Kolhāpur, Maharashtra, 416008

    Recruiting

  • Government Medical College

    Kozhikode, Kerala, 673008

    Recruiting

  • Topiwala National Medical College & BYL Nair Hospital

    Mumbai, Maharashtra, 400008

    Recruiting

  • Seth G. S. medical college and KEM hospital

    Mumbai, Maharashtra, 400012

    Recruiting

  • BSES Municipal General Hospital

    Mumbai, Maharashtra, 400058

    Recruiting

  • Lady Hardinge Medical College and S.S.K. Hospital

    New Delhi, National Capital Territory of Delhi, 110001

    Recruiting

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

    Recruiting

  • LMMF's Deenanath Mangeshkar Hospital and Research Center

    Pune, Maharashtra, 411004

    Recruiting

  • Jothydevs Diabetes Research Centre

    Trivandrum, Kerala, 695032

    Recruiting

Other trials in India

United States9 sites, 9 recruiting

  • AMR Clinical, El Dorado

    El Dorado, Kansas, 67042

    Recruiting

  • Family First Medical Research Center

    Hialeah Gardens, Florida, 33175

    Recruiting

  • Alliance for Multispecialty Research (AMR Clinical) - Wichita East

    Lakeland, Florida, 33803

    Recruiting

  • CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)

    Lakeland, Florida, 33803

    Recruiting

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

    Recruiting

  • GTL Medical & Research Group

    Miami, Florida, 33173

    Recruiting

  • AMR Clinical - Newton

    Newton, Kansas, 67114

    Recruiting

  • Lynn Health Science Institute - Oklahoma City

    Oklahoma City, Oklahoma, 73112

    Recruiting

  • Florida Institute for Clinical Research LLC

    Orlando, Florida, 32835

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Being tested
GL0034 Dose Level 1, GL0034 Dose Level 2, GL0034 Dose Level 3, GL0034 Dose Level 4, GL0034 Dose Level 5
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GL0034 Dose Level 1Drug

    Dose 1, once a week

  • GL0034 Dose Level 2Drug

    Dose 2, once a week

  • GL0034 Dose Level 3Drug

    Dose 3, once a week

  • GL0034 Dose Level 4Drug

    Dose 4, once a week

  • GL0034 Dose Level 5Drug

    Dose 5, once a week

  • GL0034 Dose Level 6Drug

    Dose 6, once a week

  • PlaceboOther

    Placebo, once a week

Study groups in NCT07282743
Study groupRoleWhat they receive
Arm 1ExperimentalDose 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.
Receives: Drug: GL0034 Dose Level 1; Drug: GL0034 Dose Level 2
Arm 2ExperimentalDose 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.
Receives: Drug: GL0034 Dose Level 1; Drug: GL0034 Dose Level 2; Drug: GL0034 Dose Level 3
Arm 3ExperimentalDose 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.
Receives: Drug: GL0034 Dose Level 1; Drug: GL0034 Dose Level 2; Drug: GL0034 Dose Level 3; Drug: GL0034 Dose Level 4
Arm 4ExperimentalDose 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.
Receives: Drug: GL0034 Dose Level 1; Drug: GL0034 Dose Level 2; Drug: GL0034 Dose Level 3; Drug: GL0034 Dose Level 4; Drug: GL0034 Dose Level 5; Drug: GL0034 Dose Level 6
PlaceboPlacebo comparatorDose 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants

    Measured: Week 36

Secondary outcomes (5)

  1. Number of participants with an HbA1c <7.0%, <6.5%, or <5.7%

    Measured: Week 36 or Week 48

  2. Change in HbA1c levels from baseline (Week 0) to Week 48 following treatments in all participants

    Measured: Week 48

  3. Change in HbA1c levels over time from baseline (Week 0) to Week 48 following treatments in all participants

    Measured: Week 48

  4. 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.

    Measured: Week 36 and Week 48

  5. 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.

    Measured: Week 36 or Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start20 Jan 2026
  3. Primary completionApr 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
285 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07282743
Sponsor's protocol ID
UTRE-24-01
Status last verified
Mar 2026
First submitted
5 Dec 2025
Last updated
18 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GL0034 Dose Level 1, GL0034 Dose Level 2 and GL0034 Dose Level 3 in people with Type II Diabetes Mellitus, run by Sun Pharmaceutical Industries Limited at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Head, Regulatory Affairs (9122 66455645, Clinical.Trial@sunpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants (time frame: Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07282743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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