Once-weekly petrelintide versus placebo for obesity or overweight with comorbidities

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Zealand Pharma A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

19 Dec 2024 → 8 Mar 2026

Decision date (initial)

2024-12-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Zealand Pharma A/S

External identifiers

EU CT number

2024-512549-18-00

WHO UTN

U1111-1305-2238

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety

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

Secondary objectives 1

1. To compare the efficacy of petrelintide versus placebo, when added as an adjunct to a reduced-calorie diet and increased physical activity, on body weight/other efficacy parameters, safety, and tolerability

Conditions and MedDRA coding

Weight management

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices

Plan to share IPD

No

IPD plan description

Not applicable

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Obtained signed informed consent prior to any trial-related procedures.
2. Age above or equal to 18 years of age or above at the time of signing informed consent.
3. 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, to be assessed at the Investigator’s discretion).
4. Male or female A female participant is eligible to participate if she is: A woman of nonchildbearing potential (see definitions in Appendix 4). 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, see Appendix 4) throughout the trial and for 10 weeks after the last injection of the IMP.
5. Ability to comply with the protocol requirements including self-administration of IMP with vial and syringe.

Exclusion criteria 5

1. Glycated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%), as measured by the central laboratory at screening.
2. History of type 1 or type 2 diabetes mellitus.
3. Treatment with glucose-lowering agent(s) within 90 days prior to screening.
4. A self-reported change in body weight >5% within 90 days prior to screening, irrespective of medical records.
5. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in body weight (%) from baseline to week 28

Secondary endpoints 2

1. Body weight loss of ≥5% from baseline to week 28 (Y/N)
2. Body weight loss of ≥10% from baseline to week 28 (Y/N)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Zealand Pharma A/S

Sponsor organisation

Zealand Pharma A/S

Address

Sydmarken 11

City

Soeborg

Postcode

2860

Country

Denmark

Scientific contact point

Organisation

Zealand Pharma A/S

Contact name

Clinical Trial Information Desk

Public contact point

Organisation

Zealand Pharma A/S

Contact name

Clinical Trial Information Desk

Third parties 12

Locations

2 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 33 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications