Obesity or OverweightPhase 3ZUPREME-5NCT07843472
A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease
A Phase 3 study testing Petrelintide in people with Obesity or Overweight and Cardiovascular Disease, run by Hoffmann-La Roche at 3 sites in United States.
Trial summary
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and established cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Obesity or Overweight, Cardiovascular Disease
- 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
- 2,500 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2026to 6 Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with BMI ≥ 27 kg/m² and established CVD
- History of at least one self-reported unsuccessful dietary effort to lose body weight
Who cannot join
- Known history of Type 1 diabetes mellitus
- Current or previous treatment with petrelintide or any other amylin analog
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: CC46446 https://forpatients.roche.com/No attachments to email below. contact
Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
United States3 sites, 3 recruiting
- Recruiting
Pinnacle Research Group
Anniston, Alabama, 36207
- Recruiting
Institute for Metabolic Research Los Angeles
Los Angeles, California, 90015
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly Petrelintide Vs. Placebo in Participants With Overweight Or Obesity And Established Cardiovascular Disease
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and established cardiovascular disease (CVD).
- Conditions
- Obesity or Overweight, Cardiovascular Disease
- Being tested
- Petrelintide, Placebo
- Medical subject headings
- Obesity, Overweight, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PetrelintideCombination product
Also called RO7895515, ZP8396
Petrelintide will be administered subcutaneously (SC) using a drug-device combination product.
PlaceboCombination product
Petrelintide-matching placebo will be administered SC using a drug-device combination product.
| Study group | Role | What they receive |
|---|---|---|
| Petrelintide | Experimental | Not described Receives: Combination Product: Petrelintide |
| Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Body Weight from Baseline
Measured: From Baseline to Week 64
Secondary outcomes (42)
Proportion of Participants Achieving ≥ 5% Body Weight Loss from Baseline
Measured: From Baseline to Week 64
Proportion of Participants Achieving ≥ 10% Body Weight Loss from Baseline
Measured: From Baseline to Week 64
Proportion of Participants Achieving ≥ 15% Body Weight Loss from Baseline
Measured: From Baseline to Week 64
Change from Baseline in Waist Circumference (cm)
Measured: From Baseline to Week 64
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Measured: From Baseline to Week 64
Change from Baseline in Triglycerides
Measured: From Baseline to Week 64
Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol
Measured: From Baseline to Week 64
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQoL-Lite-CT) Physical Functioning Composite Score
Measured: From Baseline to Week 64
Change from Baseline in IWQoL-Lite-CT Physical Functioning Composite Score in Participants with Poor Physical Functioning at Baseline (as defined by Patient Global Impression of Severity/Status [PGI-S])
Measured: From Baseline to Week 64
Change from Baseline in Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Measured: From Baseline to Week 64
Change from Baseline in SF-36v2 Acute Form Physical Functioning Domain Score in Participants with Poor Physical Functioning at Baseline (as defined by PGI-S)
Measured: From Baseline to Week 64
Change from Baseline in Mean Daily Food Craving Score
Measured: From Baseline to Week 64
Change from Baseline in Mean Daily Peak Hunger Score
Measured: From Baseline to Week 64
Change from Baseline in Body Mass Index (BMI) (kg/m²)
Measured: From Baseline to Week 64
Change from Baseline in Body Weight (kg)
Measured: From Baseline to Week 64
Change from Baseline in Waist-to-Hip Ratio
Measured: From Baseline to Week 64
Change from Baseline in Waist-to-Height Ratio
Measured: From Baseline to Week 64
Change from Baseline in Fasting Insulin
Measured: From Baseline to Week 64
Change from Baseline in Fasting Glucose
Measured: From Baseline to Week 64
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: From Baseline to Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 5.7%
Measured: At Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 6.5%
Measured: At Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 7%
Measured: At Week 64
Percentage of Participants With Baseline Prediabetes Achieving HbA1c of < 5.7%
Measured: At Week 64
Change from Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol
Measured: From Baseline to Week 64
Change from Baseline in Non-HDL Cholesterol
Measured: From Baseline to Week 64
Change from Baseline in Total Cholesterol
Measured: From Baseline to Week 64
Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol
Measured: From Baseline to Week 64
Change from Baseline in Free Fatty Acids
Measured: From Baseline to Week 64
Change from Baseline in Systolic Blood Pressure
Measured: From Baseline to Week 64
Change from Baseline in Diastolic Blood Pressure
Measured: From Baseline to Week 64
Change from Baseline in Health-Related Quality of Life (HRQoL) as assessed by SF-36v2 Acute Form Domain Scores and Component Summary Scores
Measured: From Baseline to Week 64
Change from Baseline in HRQoL as assessed by IWQoL-Lite-CT Domain Scores and Total Score
Measured: From Baseline to Week 64
Proportion of Participants with ≥ 14.6-Point Increase from Baseline in IWQoL-Lite-CT Physical Function Score
Measured: From Baseline to Week 64
Proportion of Participants with ≥ 3.7-Point Increase from Baseline in SF36v2 Physical Functioning Score
Measured: From Baseline to Week 64
Proportion of Participants with Baseline Poor Physical Functioning Achieving ≥ 14.6-Point Increase in IWQoL-Lite-CT Physical Functioning Score
Measured: From Baseline to Week 64
Proportion of Participants with Baseline Poor Physical Functioning Achieving a ≥ 3.7-Point Increase in SF36v2 Physical Functioning Score
Measured: From Baseline to Week 64
Change from Baseline in Mean Daily Average Hunger Score
Measured: From Baseline to Week 64
Change from Baseline in Mean Daily Average Satiety Score
Measured: From Baseline to Week 64
Change from Baseline in Mean Daily Average Appetite Score
Measured: From Baseline to Week 64
Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria
Measured: From Baseline to Week 64
Percentage of Participants with Baseline Anti-Drug Antibodies (ADAs) and Treatment-Emergent ADAs Against Petrelintide
Measured: From Baseline to Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start30 Sep 2026
- Primary completion28 Jul 2030 (estimated)
- Study completion6 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity or OverweightStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zealand Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843472
- Sponsor's protocol ID
- CC46446
- Other IDs
- 2026-526190-41-00
- Acronym
- ZUPREME-5
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly Petrelintide Vs. Placebo in Participants With Overweight Or Obesity And Established Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT07843472
- Acronym / sponsor ID
- ZUPREME-5 / CC46446
- Conditions
- Obesity or Overweight, Cardiovascular Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Zealand Pharma
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- 28 Jul 2030 (estimated)
- Study completion
- 6 Oct 2030 (estimated)
- First posted
- 28 Sep 2026 (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.
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and established cardiovascular disease (CVD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Petrelintide | Experimental | Combination Product: Petrelintide |
| Placebo | Placebo comparator | Combination Product: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants with BMI ≥ 27 kg/m² and established CVD
- History of at least one self-reported unsuccessful dietary effort to lose body weight
Key exclusion criteria (2 listed)
- Known history of Type 1 diabetes mellitus
- Current or previous treatment with petrelintide or any other amylin analog
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: RO7895515, ZP8396Petrelintide will be administered subcutaneously (SC) using a drug-device combination product. | Combination product | Petrelintide |
| PlaceboPetrelintide-matching placebo will be administered SC using a drug-device combination product. | Combination product | Placebo |
Primary outcome
Percentage Change in Body Weight from Baseline
Time frame: From Baseline to Week 64
42 secondary outcomes
Proportion of Participants Achieving ≥ 5% Body Weight Loss from Baseline
Time frame: From Baseline to Week 64
Proportion of Participants Achieving ≥ 10% Body Weight Loss from Baseline
Time frame: From Baseline to Week 64
Proportion of Participants Achieving ≥ 15% Body Weight Loss from Baseline
Time frame: From Baseline to Week 64
Change from Baseline in Waist Circumference (cm)
Time frame: From Baseline to Week 64
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: From Baseline to Week 64
Change from Baseline in Triglycerides
Time frame: From Baseline to Week 64
Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol
Time frame: From Baseline to Week 64
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQoL-Lite-CT) Physical Functioning Composite Score
Time frame: From Baseline to Week 64
Change from Baseline in IWQoL-Lite-CT Physical Functioning Composite Score in Participants with Poor Physical Functioning at Baseline (as defined by Patient Global Impression of Severity/Status [PGI-S])
Time frame: From Baseline to Week 64
Change from Baseline in Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Time frame: From Baseline to Week 64
Change from Baseline in SF-36v2 Acute Form Physical Functioning Domain Score in Participants with Poor Physical Functioning at Baseline (as defined by PGI-S)
Time frame: From Baseline to Week 64
Change from Baseline in Mean Daily Food Craving Score
Time frame: From Baseline to Week 64
Change from Baseline in Mean Daily Peak Hunger Score
Time frame: From Baseline to Week 64
Change from Baseline in Body Mass Index (BMI) (kg/m²)
Time frame: From Baseline to Week 64
Change from Baseline in Body Weight (kg)
Time frame: From Baseline to Week 64
Change from Baseline in Waist-to-Hip Ratio
Time frame: From Baseline to Week 64
Change from Baseline in Waist-to-Height Ratio
Time frame: From Baseline to Week 64
Change from Baseline in Fasting Insulin
Time frame: From Baseline to Week 64
Change from Baseline in Fasting Glucose
Time frame: From Baseline to Week 64
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: From Baseline to Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 5.7%
Time frame: At Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 6.5%
Time frame: At Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 7%
Time frame: At Week 64
Percentage of Participants With Baseline Prediabetes Achieving HbA1c of < 5.7%
Time frame: At Week 64
Change from Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol
Time frame: From Baseline to Week 64
Change from Baseline in Non-HDL Cholesterol
Time frame: From Baseline to Week 64
Change from Baseline in Total Cholesterol
Time frame: From Baseline to Week 64
Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol
Time frame: From Baseline to Week 64
Change from Baseline in Free Fatty Acids
Time frame: From Baseline to Week 64
Change from Baseline in Systolic Blood Pressure
Time frame: From Baseline to Week 64
Change from Baseline in Diastolic Blood Pressure
Time frame: From Baseline to Week 64
Change from Baseline in Health-Related Quality of Life (HRQoL) as assessed by SF-36v2 Acute Form Domain Scores and Component Summary Scores
Time frame: From Baseline to Week 64
Change from Baseline in HRQoL as assessed by IWQoL-Lite-CT Domain Scores and Total Score
Time frame: From Baseline to Week 64
Proportion of Participants with ≥ 14.6-Point Increase from Baseline in IWQoL-Lite-CT Physical Function Score
Time frame: From Baseline to Week 64
Proportion of Participants with ≥ 3.7-Point Increase from Baseline in SF36v2 Physical Functioning Score
Time frame: From Baseline to Week 64
Proportion of Participants with Baseline Poor Physical Functioning Achieving ≥ 14.6-Point Increase in IWQoL-Lite-CT Physical Functioning Score
Time frame: From Baseline to Week 64
Proportion of Participants with Baseline Poor Physical Functioning Achieving a ≥ 3.7-Point Increase in SF36v2 Physical Functioning Score
Time frame: From Baseline to Week 64
Change from Baseline in Mean Daily Average Hunger Score
Time frame: From Baseline to Week 64
Change from Baseline in Mean Daily Average Satiety Score
Time frame: From Baseline to Week 64
Change from Baseline in Mean Daily Average Appetite Score
Time frame: From Baseline to Week 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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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.
Reference Study ID Number: CC46446 https://forpatients.roche.com/No attachments to email below. contact
Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Petrelintide in people with Obesity or Overweight and Cardiovascular Disease, run by Hoffmann-La Roche at 3 sites in United States.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: CC46446 https://forpatients.roche.com/No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Body Weight from Baseline (time frame: From Baseline to Week 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.