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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

Arm	Description	Assigned 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.

Recruiting Locations

More Details

NCT ID: NCT06926842
Status: Active, not recruiting
Sponsor: Zealand Pharma

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.