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.
• 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.