ObesityPhase 2ZUPREMENCT06662539
Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities
A Phase 2 study testing Petrelintide in people with Obesity, run by Zealand Pharma at 32 sites in 3 countries.
Trial summary
The main purpose of this study is to compare dose levels of petrelintide versus placebo with regards to effect on body weight, safety, and tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Petrelintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 493 participants
- Where
- 32 sitesin 3 countries
- Study dates
- 9 Dec 2024to 7 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants having body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 with the presence of at least one of the following comorbidities: hypertension or dyslipidemia (treated or untreated).
- A female participant is eligible to participate if she is:
- A woman of nonchildbearing potential. OR
- A woman of childbearing potential (WOCBP) who is not pregnant, does not intend to be pregnant, not lactating and is willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial and for 10 weeks after the last injection of the investigational medicinal product (IMP).
- Ability to comply with the protocol requirements including self-administration of IMP with vial and syringe.
Who cannot join
- Glycated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%), as measured at screening.
- History of type 1 or type 2 diabetes mellitus.
- Treatment with glucose lowering agent(s) within 90 days prior to screening.
- A self-reported change in body weight >5% within 90 days prior to screening.
- 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.
Show all 19Show fewer
- Uncontrolled thyroid disease defined as thyroid stimulating hormone >4.20 mIU/L or <0.27 mIU/L as measured by the central laboratory at screening.
- Lifetime history of a suicidal attempt.
- History of major depressive disorder or other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder).
- Estimated glomerular filtration rate value <60.0 mL/min/1.73m2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation17, measured at screening.
- Impaired liver function, defined as alanine aminotransferase and/or aspartate aminotransferase ≥2.0 times or bilirubin >1.5 times upper normal limit, measured at screening.
- Presence or history of acute or chronic pancreatitis.
- Known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronic treatment that affects gastrointestinal (GI) motility.
- Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation.
- Presence or history of clinically significant arrhythmias or clinically significant conduction disorders.
- Known or suspected hypersensitivity to amylin analogs or related products.
- History of malignant neoplasms (except for basal or squamous cell skin cancer) within 5 years prior to screening.
- Known or suspected abuse of alcohol or recreational drugs.
- Participant previously treated with petrelintide or any other amylin analog.
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
United States19 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, 33434
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
Javara Inc
Charlotte, North Carolina, 28210
Great Lakes Clinical Trials LLC dba Flourish Research
Chicago, Illinois, 60640
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Altoona Center for Clinical Research - Research
Duncansville, Pennsylvania, 16635
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, 27408
Alliance for Multispecialty Research
Knoxville, Tennessee, 37909
Alliance For Multispecialty Research, LLC
Lexington, Kentucky, 40509
Manaasas Clinical Research Center
Manassas, Virginia, 20110
Century Research LLC
Miami, Florida, 33155
Lucas Research, Inc.
New Bern, North Carolina, 28562
AMR Norman
Norman, Oklahoma, 73069
Clinical Research Center of Florida
Pompano Beach, Florida, 33060-6977
Clinical Trials of Texas, LLC., dba Flourish Research
San Antonio, Texas, 78229
CHEAR Center LLC
The Bronx, New York, 10455
Palm Beach Research Center
West Palm Beach, Florida, 33409
AMR Wichita East
Wichita, Kansas, 67226
Poland7 sites
Krakowskie Centrum MedyczneSp.z o.o
Krakow, Lesser Poland Voivodeship, 31-501
Futuremeds Olsztyn
Olsztyn, Warmian-Masurian Voivodeship, 10-165
ETG Siedlce
Siedlce, Masovian Voivodeship, 08-110
FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, 00-215
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, Masovian Voivodeship, 02-507
ETG Warszawa
Warsaw, Masovian Voivodeship, 02-677
FutureMeds Targowek
Warsaw, Masovian Voivodeship, 03-291
Romania6 sites
Institutul National de Endocrinologie C I Parhon
Bucharest, 011863
Institutul Clinic Fundeni
Bucharest, 022328
Fundatia Dr Victor Babes
Bucharest, 030303
Institutul De Pneumoftiziologie Marius Nasta
Bucharest, 050159
Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei Constanta
Constanța, 900591
Top Diabet
Craiova, Dolj, 200515
About this study
Official title: A Randomized, Double-blind, Phase 2, Dose-finding Trial of Once Weekly Petrelintide Compared With Placebo in Participants With Obesity or Overweight With Weight Related Comorbidities
The main purpose of this study is to compare dose levels of petrelintide versus placebo with regards to effect on body weight, safety, and tolerability.
Read the detailed description
Obesity is a chronic disease with a rapidly increasing prevalence associated with significant comorbidities. Petrelintide is a long-acting amylin analog in development for weight management.
This is a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter, dose-finding, Phase 2 clinical trial. The trial will compare 5 doses of once-weekly (OW) subcutaneously administered petrelintide with placebo.
This study consists of 3 periods:
- A screening period of 2-3 weeks
- A treatment period of 42 weeks
- A safety follow-up period of 9 weeks.
- Conditions
- Obesity
- Being tested
- Petrelintide, Placebo
- Keywords
- Weight management, Amylin analog
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PetrelintideDrug
Also called ZP8396
Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
PlaceboDrug
Matching placebo to petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Petrelintide Dose 1 | Experimental | Participants will self-inject petrelintide dose 1 subcutaneously once a week. Receives: Drug: Petrelintide |
| Petrelintide Dose 2 | Experimental | Participants will self-inject petrelintide dose 2 subcutaneously once a week. Receives: Drug: Petrelintide |
| Petrelintide Dose 3 | Experimental | Participants will self-inject petrelintide dose 3 subcutaneously once a week. Receives: Drug: Petrelintide |
| Petrelintide Dose 4 | Experimental | Participants will self-inject petrelintide dose 4 subcutaneously once a week. Receives: Drug: Petrelintide |
| Petrelintide Dose 5 | Experimental | Participants will self-inject petrelintide dose 5 subcutaneously once a week. Receives: Drug: Petrelintide |
| Placebo | Placebo comparator | Participants will self-inject matching placebo to petrelintide subcutaneously once a week. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in body weight to Week 28
To compare the dose-response of increasing doses of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity after 28 weeks of exposure.
Measured: From Baseline (Day 1) to Week 28
Secondary outcomes (11)
Percentage of Participants achieving ≥5% Body Weight Loss at Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Weeks 28 and 42
Percentage of Participants achieving ≥10% Body Weight Loss at Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Weeks 28 and 42
Change from baseline in body weight to Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Weeks 28 and 42
Change from baseline in waist circumference to Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on waist circumference, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Weeks 28 and 42
Percent change from baseline in body weight to Week 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Week 42
Change from baseline in hemoglobin A1c (HbA1c) to Week 42
To compare the efficacy of petrelintide versus placebo on HbA1c, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Week 42
Change from baseline in fasting glucose to Week 42
To compare the efficacy of petrelintide versus placebo on fasting glucose, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Week 42
Change from baseline in high-sensitivity C-reactive protein (hsCRP) to Week 42
To compare the efficacy of petrelintide versus placebo on hsCRP, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Week 42
Change from baseline in fasting lipids to Week 42
To compare the efficacy of petrelintide versus placebo on fasting lipids, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Week 42
Number of treatment emergent adverse events (TEAEs)
To compare the safety and tolerability of petrelintide versus placebo when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Week 51
Occurrences of anti-drug antibodies (ADAs) to petrelintide
To compare the safety and tolerability of petrelintide versus placebo when added as an adjunct to a reduced-calorie diet and increased physical activity.
Measured: From Baseline (Day 1) to Week 51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start9 Dec 2024
- Primary completion30 Sep 2025
- Study completion7 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662539
- Sponsor's protocol ID
- ZP8396-23094
- Other IDs
- 2024-512549-18
- Acronym
- ZUPREME
- Status last verified
- Mar 2026
- First submitted
- 25 Oct 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garvey WT, Ard J, Connery L, Frias JP, le Roux CW, Pietilainen KH, Dinesen M, Hagen BF, Larsen L, Hesse D, Kendall DM. Petrelintide, a human amylin analogue for the treatment of obesity (ZUPREME 1): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2026 Sep 29:S2213-8587(26)00213-5. doi: 10.1016/S2213-8587(26)00213-5. Online ahead of print.
PubMed 42810355
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase 2, Dose-finding Trial of Once Weekly Petrelintide Compared With Placebo in Participants With Obesity or Overweight With Weight Related Comorbidities
- ClinicalTrials.gov ID
- NCT06662539
- Acronym / sponsor ID
- ZUPREME / ZP8396-23094
- Conditions
- Obesity
- Keywords
- Weight management, Amylin analog
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 7 Mar 2026 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to compare dose levels of petrelintide versus placebo with regards to effect on body weight, safety, and tolerability.
Detailed description
Obesity is a chronic disease with a rapidly increasing prevalence associated with significant comorbidities. Petrelintide is a long-acting amylin analog in development for weight management.
This is a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter, dose-finding, Phase 2 clinical trial. The trial will compare 5 doses of once-weekly (OW) subcutaneously administered petrelintide with placebo.
This study consists of 3 periods:
- A screening period of 2-3 weeks
- A treatment period of 42 weeks
- A safety follow-up period of 9 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Petrelintide Dose 1 | Experimental | Drug: PetrelintideParticipants will self-inject petrelintide dose 1 subcutaneously once a week. |
| Petrelintide Dose 2 | Experimental | Drug: PetrelintideParticipants will self-inject petrelintide dose 2 subcutaneously once a week. |
| Petrelintide Dose 3 | Experimental | Drug: PetrelintideParticipants will self-inject petrelintide dose 3 subcutaneously once a week. |
| Petrelintide Dose 4 | Experimental | Drug: PetrelintideParticipants will self-inject petrelintide dose 4 subcutaneously once a week. |
| Petrelintide Dose 5 | Experimental | Drug: PetrelintideParticipants will self-inject petrelintide dose 5 subcutaneously once a week. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will self-inject matching placebo to petrelintide subcutaneously once a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants having body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 with the presence of at least one of the following comorbidities: hypertension or dyslipidemia (treated or untreated).
- A female participant is eligible to participate if she is:
- Ability to comply with the protocol requirements including self-administration of IMP with vial and syringe.
Key exclusion criteria (19 listed)
- Glycated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%), as measured at screening.
- History of type 1 or type 2 diabetes mellitus.
- Treatment with glucose lowering agent(s) within 90 days prior to screening.
- A self-reported change in body weight >5% within 90 days prior to screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PetrelintideAlso: ZP8396Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection. | Drug | Petrelintide Dose 1, Petrelintide Dose 2, Petrelintide Dose 3, Petrelintide Dose 4, Petrelintide Dose 5 |
| PlaceboMatching placebo to petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection. | Drug | Placebo |
Primary outcome
Percent change from baseline in body weight to Week 28
Time frame: From Baseline (Day 1) to Week 28
To compare the dose-response of increasing doses of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity after 28 weeks of exposure.
11 secondary outcomes
Percentage of Participants achieving ≥5% Body Weight Loss at Weeks 28 and 42
Time frame: From Baseline (Day 1) to Weeks 28 and 42
Percentage of Participants achieving ≥10% Body Weight Loss at Weeks 28 and 42
Time frame: From Baseline (Day 1) to Weeks 28 and 42
Change from baseline in body weight to Weeks 28 and 42
Time frame: From Baseline (Day 1) to Weeks 28 and 42
Change from baseline in waist circumference to Weeks 28 and 42
Time frame: From Baseline (Day 1) to Weeks 28 and 42
Percent change from baseline in body weight to Week 42
Time frame: From Baseline (Day 1) to Week 42
Change from baseline in hemoglobin A1c (HbA1c) to Week 42
Time frame: From Baseline (Day 1) to Week 42
Change from baseline in fasting glucose to Week 42
Time frame: From Baseline (Day 1) to Week 42
Change from baseline in high-sensitivity C-reactive protein (hsCRP) to Week 42
Time frame: From Baseline (Day 1) to Week 42
Change from baseline in fasting lipids to Week 42
Time frame: From Baseline (Day 1) to Week 42
Number of treatment emergent adverse events (TEAEs)
Time frame: From Baseline (Day 1) to Week 51
Occurrences of anti-drug antibodies (ADAs) to petrelintide
Time frame: From Baseline (Day 1) to Week 51
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 42810355Garvey WT, Ard J, Connery L, Frias JP, le Roux CW, Pietilainen KH, Dinesen M, Hagen BF, Larsen L, Hesse D, Kendall DM. Petrelintide, a human amylin analogue for the treatment of obesity (ZUPREME 1): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2026 Sep 29:S2213-8587(26)00213-5. doi: 10.1016/S2213-8587(26)00213-5. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Petrelintide in people with Obesity, run by Zealand Pharma at 32 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Poland, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in body weight to Week 28 (time frame: From Baseline (Day 1) to Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.