Clinical trial NCT06926842: Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
Official title: A Randomized, Double-Blind, Phase 2 Trial of Once-Weekly Petrelintide Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Overweight
Type 2 Diabetes
Obesity
Keywords: Long-acting amylin analogues
Weight management
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2025-04-15
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage Change in Body Weight
timeFrame: From Baseline (Day 1) to Weeks 28
Secondary outcomes:
measure: Number of Participants Achieving ≥5% Body Weight Loss
timeFrame: From Baseline (Day 1) to Weeks 28
measure: Number of Participants Achieving ≥10% Body Weight Loss
timeFrame: From Baseline (Day 1) to Weeks 28
measure: Change in Body Weight (kilogram)
timeFrame: From Baseline (Day 1) to Weeks 28
measure: Change in Waist Circumference
timeFrame: From Baseline (Day 1) to Weeks 28
measure: Change in Glycated Hemoglobin (HbA1c)
timeFrame: From Baseline (Day 1) to Weeks 28
measure: Change in Fasting Glucose
timeFrame: From Baseline (Day 1) to Weeks 28
measure: Change in High-Sensitivity C-reactive protein (hsCRP)
timeFrame: From Baseline (Day 1) to Weeks 28
measure: Number of Participants Achieving <7% HbA1c
timeFrame: From Baseline (Day 1) to Weeks 28
measure: Number of Participants Achieving ≤6.5% HbA1c
timeFrame: From Baseline (Day 1) to Weeks 28
measure: Changes in Fasting Lipids
timeFrame: From Baseline (Day 1) to Weeks 28
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: From Baseline (Day 1) to Weeks 38
measure: Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38
timeFrame: From Baseline (Day 1) to Weeks 38
measure: Number of Participants with Positive Anti-Drug Antibodies (ADAs)
timeFrame: From Baseline (Day 1) to Weeks 38
measure: Change in Systolic Blood Pressure
timeFrame: From Baseline (Day 1) to Week 38
measure: Change in Diastolic Blood Pressure
timeFrame: From Baseline (Day 1) to Week 38
measure: Change in Pulse Rate
timeFrame: From Baseline (Day 1) to Week 38
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Clinical Trials - Family Medicine
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Little Rock
country: United States
facility: Medical Investigation Inc
state: Arkansas
city: Escondido
country: United States
facility: AMCR Institute, Inc.
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research Inc.
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology P.A
state: Florida
city: Canton
country: United States
facility: East Coast Institute for Research - Canton
state: Georgia
city: West Des Moines
country: United States
facility: Iowa Diabetes & Endocrinology Research Center
state: Iowa
city: New Orleans
country: United States
facility: DelRicht Research - New Orleans
state: Louisiana
city: Flint
country: United States
facility: AAMRC
state: Michigan
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Las Vegas
country: United States
facility: Palm Research Center, Inc.
state: Nevada
city: Greensboro
country: United States
facility: PharmQuest Life Sciences, LLC
state: North Carolina
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Austin
country: United States
facility: Elligo Clinical Research, Inc.
state: Texas
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Juno Research LLC
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research
state: Texas
city: Manassas
country: United States
facility: Manaasas Clinical Research Center
state: Virginia
Study officials:
References: