A Research Study to See How NNC0487-0111 Affects the Body's Energy Use After a Weight Loss in Adults Living With Overweight or Obesity, Compared to a Low-calorie Diet or Placebo

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

The purpose of this clinical study is to evaluate how NNC0487-0111 affects the amount of energy the body uses in people living with obesity or overweight following weight loss. This will be compared with the amount of energy used by participants who achieve weight loss through a low-calorie diet and by participants receiving placebo (without weight loss).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female (sex assigned at birth, inclusive of all gender identities).

Age 18 years or older at the time of signing the informed consent.

Disqualifiers

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.

Exposure to an investigational medicinal product within 30 days.

Any condition, or disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Anticipated change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study, for example, an imminent job change to/from a physically demanding occupation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NNC0487-0111

    Drug

    NNC0487-0111 will be administered subcutaneously.

  • Placebo

    Drug

    Placebo matched to NNC0487-0111 will be administered subcutaneously.

  • LED

    Behavioral

    A meal plan and meal replacements will be provided by the investigators.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: NNC0487-0111Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Low Energy Diet (LED)Other 1 intervention

Trial outcomes

Primary outcomes

1

Change in sleeping metabolic rate (SMR)

Measured in kilojoules per day (kJ/day)

Time frame
Baseline (week 0) to week 12-26

Secondary outcomes

1

Change in 24-hour energy expenditure (EE)

Measured in kJ/day.

Time frame
Baseline (week 0) to week 12-26
2

Change in basal metabolic rate (BMR)

Measured in kJ/day.

Time frame
Baseline (week 0) to week 12-26
3

Change in resting metabolic rate (RMR)

Measured in kJ/day.

Time frame
Baseline (week 0) to week 12-26
4

Change in diet-induced thermogenesis (DIT)

Measured in kJ/day.

Time frame
Baseline (week 0) to week 12-26

Other outcomes

Sponsors and contacts

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