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

Zealand Pharma

Status and phase: Enrolling; Phase 2

Conditions: Overweight; Obesity; Type 2 Diabetes

Treatments: Other: Placebo; Drug: Petrelintide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06926842

ZP8396-24115

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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 6 months 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 6 patient groups, including a placebo group

Treatment A: Petrelintide Dose 1

Experimental group

Description:

Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.

Treatment:

Drug: Petrelintide

Treatment B: Petrelintide Placebo Dose 1

Placebo Comparator group

Description:

Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.

Treatment:

Other: Placebo

Treatment C: Petrelintide Dose 2

Experimental group

Description:

Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.

Treatment:

Drug: Petrelintide

Treatment D: Petrelintide Placebo Dose 2

Placebo Comparator group

Description:

Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.

Treatment:

Other: Placebo

Treatment E: Petrelintide Dose 3

Experimental group

Description:

Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.

Treatment:

Drug: Petrelintide

Treatment F: Petrelintide Placebo Dose 3

Placebo Comparator group

Description:

Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.

Treatment:

Other: Placebo