Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)

Purpose

The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.

Conditions

  • Overweight
  • Type 2 Diabetes
  • Obesity

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female participants with body mass index (BMI) ≥27.0 kg/m2. - Diagnosed with type 2 diabetes ≥180 days prior to the day of screening. - Treated with metformin with or without sodium-glucose cotransporter 2 inhibitors. Treatment should be stable (same drug[s], dose, and dosing frequency) for at least 90 days prior to screening. Main

Exclusion Criteria

  • Severe hypoglycemia within 6 months prior to screening or history of hypoglycemia unawareness. - Receipt of any other glucose-lowering drug than those listed in the inclusion criterion within 90 days prior to screening. - A self-reported change in body weight >5% within 90 days prior to screening, irrespective of medical records. - Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 90 days prior to screening. - Previous or planned (during the trial period) obesity treatment with surgery or a body weight loss device. However, liposuction or surgical removal of fat depots more than 1 year prior to screening or device-based interventions (e.g., sleeve, banding, or similar) that have been removed more than 6 months prior to screening, are allowed. - Obesity due to endocrine disorders or genetic syndromes.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment A: Petrelintide Dose 1 		Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.
  • Drug: Petrelintide
    Petrelintide will be taken by participants once weekly subcutaneously.
    Other names:
    • ZP8396
Placebo Comparator
Treatment B: Petrelintide Placebo Dose 1 		Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
  • Other: Placebo
    Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Experimental
Treatment C: Petrelintide Dose 2 		Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.
  • Drug: Petrelintide
    Petrelintide will be taken by participants once weekly subcutaneously.
    Other names:
    • ZP8396
Placebo Comparator
Treatment D: Petrelintide Placebo Dose 2 		Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
  • Other: Placebo
    Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Experimental
Treatment E: Petrelintide Dose 3 		Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.
  • Drug: Petrelintide
    Petrelintide will be taken by participants once weekly subcutaneously.
    Other names:
    • ZP8396
Placebo Comparator
Treatment F: Petrelintide Placebo Dose 3 		Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
  • Other: Placebo
    Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.

More Details

Status
Active, not recruiting
Sponsor
Zealand Pharma

Study Contact