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

NCT07282743 | Recruiting Phase 2 FDA Drug

• 1 other identifier: UTRE-24-01
• Study Type: interventional
• Target: 285
• Locations: 2 countries
• Sites: 21

Brief 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. 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.

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  Week 36

Secondary Outcomes (5)

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

  Week 36 or Week 48

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

  Week 48

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

  Week 48

• 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.

  Week 36 and Week 48

• 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.

  Week 36 or Week 48

Study Arms (5)

Arm 1

EXPERIMENTAL

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.

Drug: GL0034 Dose Level 1; Drug: GL0034 Dose Level 2

Arm 2

EXPERIMENTAL

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.

Drug: GL0034 Dose Level 1; Drug: GL0034 Dose Level 2; Drug: GL0034 Dose Level 3

Arm 3

EXPERIMENTAL

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.

Drug: GL0034 Dose Level 1; Drug: GL0034 Dose Level 2; Drug: GL0034 Dose Level 3; Drug: GL0034 Dose Level 4

Arm 4

EXPERIMENTAL

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.

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

Placebo

PLACEBO 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.

Other: Placebo

Interventions

GL0034 Dose Level 1 DRUG

Dose 1, once a week

Arm 1; Arm 2; Arm 3; Arm 4

GL0034 Dose Level 2 DRUG

Dose 2, once a week

Arm 1; Arm 2; Arm 3; Arm 4

GL0034 Dose Level 3 DRUG

Dose 3, once a week

Arm 2; Arm 3; Arm 4

GL0034 Dose Level 4 DRUG

Dose 4, once a week

Arm 3; Arm 4

GL0034 Dose Level 5 DRUG

Dose 5, once a week

Arm 4

GL0034 Dose Level 6 DRUG

Dose 6, once a week

Arm 4

Placebo OTHER

Placebo, once a week

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (21)

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72204, United States

RECRUITING

Family First Medical Research Center

Hialeah Gardens, Florida, 33175, United States

RECRUITING

Alliance for Multispecialty Research (AMR Clinical) - Wichita East

Lakeland, Florida, 33803, United States

RECRUITING

CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)

Lakeland, Florida, 33803, United States

RECRUITING

GTL Medical & Research Group

Miami, Florida, 33173, United States

RECRUITING

Florida Institute for Clinical Research LLC

Orlando, Florida, 32835, United States

RECRUITING

AMR Clinical, El Dorado

El Dorado, Kansas, 67042, United States

RECRUITING

AMR Clinical - Newton

Newton, Kansas, 67114, United States

RECRUITING

Lynn Health Science Institute - Oklahoma City

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Endolife Specialty Hospitals Pvt. Ltd.

Guntur, Andhra Pradesh, 522001, India

RECRUITING

Life Care Hospital and Research Centre

Bangalore, Karnataka, 560092, India

RECRUITING

Government Medical College

Kozhikode, Kerala, 673008, India

RECRUITING

Jothydevs Diabetes Research Centre

Trivandrum, Kerala, 695032, India

RECRUITING

Nirmal Hospital Private Limited

Kolhāpur, Maharashtra, 416008, India

RECRUITING

Topiwala National Medical College & BYL Nair Hospital

Mumbai, Maharashtra, 400008, India

RECRUITING

Seth G. S. medical college and KEM hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

BSES Municipal General Hospital

Mumbai, Maharashtra, 400058, India

RECRUITING

LMMF's Deenanath Mangeshkar Hospital and Research Center

Pune, Maharashtra, 411004, India

RECRUITING

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

New Delhi, National Capital Territory of Delhi, 110001, India

RECRUITING

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Madras Diabetes Research Foundation (MDRF)

Chennai, Tamil Nadu, 600086, India

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Head, Regulatory Affairs

CONTACT

9122 66455645; Clinical.Trial@sunpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 15, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (9); IN (12)