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

Conditions

• Type II Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GL0034 Dose Level 1 — DRUG
  Dose 1, once a week
• GL0034 Dose Level 2 — DRUG
  Dose 2, once a week
• GL0034 Dose Level 3 — DRUG
  Dose 3, once a week
• GL0034 Dose Level 4 — DRUG
  Dose 4, once a week
• GL0034 Dose Level 5 — DRUG
  Dose 5, once a week
• GL0034 Dose Level 6 — DRUG
  Dose 6, once a week
• Placebo — OTHER
  Placebo, once a week

Study Details

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.

Key Dates

Start date

Jan 20, 2026

Status verified

Mar 2026

Primary completion

Apr 30, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

285 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  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.
• Experimental: Arm 2
  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.
• Experimental: Arm 3
  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.
• Experimental: Arm 4
  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.
• Placebo Comparator: Placebo
  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.

Primary Outcome Measure

Change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants [ Time Frame: Week 36 ]

Central Contacts

• Head, Regulatory Affairs
  9122 66455645
  [email protected]

Locations (9)

Find similar trials in Little Rock, AR

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